Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.

Name: Kaimen Rigor review — Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.
Item: Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.
Rating: 100
Author: Alpha1

Ryan DH, Lingvay I, Deanfield J, Kahn SE, Barros E, Burguera B, Colhoun HM, Cercato C, Dicker D, Horn DB, Hovingh GK, Jeppesen OK, Kokkinos A, Lincoff AM, Meyhöfer SM, Oral TK, Plutzky J, van Beek AP, Wilding JPH, Kushner RF

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Kaimen Rigor review — 4.5★ (Strong), 0 critical, 0 high issues for “Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.

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DOI

10.1038/s41591-024-02996-7

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.

Paper source

Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4.5 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary efficacy claim is weight loss and anthropometric changes (waist circumference, waist-to-height ratio, BMI category), which are surrogate markers for clinical outcomes. The paper does not demonstrate target engagement at the tested dose (e.g., PK/PD) nor cite validated evidence linking these surrogates to hard clinical outcomes in this context. Although the SELECT trial showed a 20% reduction in MACE, this analysis focuses on weight and anthropometrics, not the hard outcome.
“At 208 weeks, semaglutide was associated with mean reduction in weight (−10.2%), waist circumference (−7.7 cm) and waist-to-height ratio (−6.9%) versus placebo (−1.5%, −1.3 cm and −1.0%, respectively; P < 0.0001 for all comparisons versus placebo).”
Find in source

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit3 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and well-reported prespecified secondary analysis of a large randomized controlled trial. The paper demonstrates strong methodological rigor across all eight dimensions, with only minor reporting gaps (e.g., randomization method not detailed, no explicit reporting guideline statement, assumptions not explicitly verified).

Both reviewers classified the study as interventional, and this was adopted. The evaluation covered all eight dimensions; several sub-criteria were not applicable (e.g., animal-related, cell line, code sharing). The statistics verification checked 4 tests, all consistent; the citation check found no retracted or unresolved references; the reproducibility check confirmed the data link is live.

Numerical inconsistencies

None found

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Checked — nothing surfaced.

Recomputed 4 tests: 4 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 3 via agent-written checks.

Overstated conclusions

1 finding · worst high

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Efficacy rests on an unvalidated surrogate endpointAssessed

6 major claims checked against the paper's own evidence: all adequately supported.

Premise concern: surrogate not validated for clinical benefit.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites prior work on obesity prevalence, the relationship between body fat and cardiovascular disease, and the development of weight-management medications including semaglutide. It acknowledges the challenge of sustaining weight loss with lifestyle intervention alone and references prior semaglutide trials (e.g., STEP 1). The rationale for this prespecified analysis is clearly stated: to evaluate weight loss and anthropometric outcomes in a diverse population over 208 weeks. Limitations of prior research are implicitly addressed by noting the need for long-term data in diverse populations.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior research on obesity, weight loss, and semaglutide, and logically links it to the study objectives.

Evidence

paraphrase[Introduction, paragraph 3]

“In STEP 1, a large phase 3 study of once-weekly subcutaneous semaglutide 2.4 mg in individuals without diabetes but with BMI >30 kg m − 2 or 27 kg m − 2 with at least one obesity-related comorbidity, the mean weight loss was −14.9% at week 68, compared with −2.4% with placebo.”

“This prespecified analysis of the SELECT trial investigated weight loss and changes in anthropometric indices in patients with established CVD and overweight or obesity without diabetes, who met inclusion and exclusion criteria, within a range of baseline categories for glycemia, renal function and body anthropometric measures.”

IntroductionFind in source

“These data, representing the longest clinical trial of the effects of semaglutide versus placebo on weight, establish the safety and durability of semaglutide effects on weight loss and maintenance in a geographically and racially diverse population of adult men and women with overweight and obesity but not diabetes.”

Discussion ¶1Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research on obesity, weight loss, and semaglutide, and logically links it to the study objectives.

Evidence

paraphrase[Introduction, paragraph 2]

paraphrase[Introduction, paragraph 4]

“Data derived from the SELECT trial offer the opportunity to evaluate the weight loss efficacy, in a geographically and racially diverse population, of semaglutide compared with placebo over 208 weeks when both are given in addition to standard-of-care recommendations for secondary CVD prevention.”

paraphrase[Introduction, paragraph 2]

“Producing and sustaining durable and clinically significant weight loss with lifestyle intervention alone has been challenging.”

The trial is described as randomized, double-blind, and placebo-controlled. Randomization method is not detailed in this paper but is referenced to prior publications; however, the design is standard for a large trial. Blinding is stated (double-blind). Power analysis is not reported in this paper, but the trial is a large cardiovascular outcomes trial with a prespecified analysis; the primary trial was adequately powered. Inclusion/exclusion criteria are described (age ≥45, BMI ≥27, established CVD). Outlier handling is not explicitly discussed, but missing data are handled via multiple imputation. Controls are the placebo group. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisNOT REPORTED

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is rigorous: randomized, double-blind, placebo-controlled, with prespecified analyses and appropriate statistical methods.

Evidence

“Patients were randomly assigned in a double-blind manner and 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo.”

MethodsFind in source

“Eligible patients were aged ≥45 years, with a BMI of ≥27 kg m − 2 and established CVD defined as at least one of the following: prior myocardial infarction, prior ischemic or hemorrhagic stroke, or symptomatic peripheral artery disease.”

MethodsFind in source

“Missing data at the landmark visit, for example, week 104, were imputed using a multiple imputation model and done separately for each treatment arm and included baseline value as a covariate and fit to patients having an observed data point (irrespective of adherence to randomized treatment) at week 104.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The study design is rigorous: randomized, double-blind, placebo-controlled, with prespecified analyses and appropriate statistical methods.

Evidence

“Patients were randomly assigned in a double-blind manner and 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“Missing data at the landmark visit, for example, week 104, were imputed using a multiple imputation model and done separately for each treatment arm and included baseline value as a covariate.”

Sex is reported (72.3% male). Age and BMI are reported (mean age 61.6 years, BMI 33.3). Demographics include race and region. Health status is described via inclusion criteria (established CVD, no diabetes). Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported: sex, age, BMI, race, and other demographics are described.

Evidence

“The SELECT study enrolled 17,604 patients (72.3% male) from 41 countries between October 2018 and March 2021, with a mean (s.d.) age of 61.6 (8.9) years and BMI of 33.3 (5.0) kg m − 2”

ResultsFind in source

“Of note, in the lower BMI categories (<30 kg m − 2 (overweight) and 30 to <35 kg m − 2 (class I obesity)), the proportion of Asian individuals was higher (14.5% and 7.4%, respectively) compared with the proportion of Asian individuals in the higher BMI categories (BMI 35 to <40 kg m − 2 (class II obesity; 3.8%) and ≥40 kg m − 2 (class III obesity; 2.2%), respectively).”

ResultsFind in source

PASSReviewer 2· 90% conf

Biological variables are well reported: sex, age, BMI, race, and other demographics are described.

Evidence

paraphrase[Results, Study population]

“The SELECT study enrolled 17,604 patients (72.3% male) from 41 countries between October 2018 and March 2021, with a mean (s.d.) age of 61.6 (8.9) years and BMI of 33.3 (5.0) kg m − 2.”

paraphrase[Results, Study population]

The paper states that the protocol was approved by national and institutional regulatory and ethical authorities in each participating country, and all patients provided written informed consent. This satisfies both IRB approval and informed consent requirements. Regulatory compliance is implied by adherence to ethical regulations.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approvals and informed consent are adequately reported.

Evidence

“The protocol for SELECT was approved by national and institutional regulatory and ethical authorities in each participating country.”

MethodsFind in source

“All patients provided written informed consent before beginning any trial-specific activity.”

MethodsFind in source

PASSReviewer 2· 90% conf

Ethical approvals and informed consent are adequately reported.

Evidence

“The protocol for SELECT was approved by national and institutional regulatory and ethical authorities in each participating country.”

MethodsFind in source

“All patients provided written informed consent before beginning any trial-specific activity.”

MethodsFind in source

paraphrase[Methods, Trial design and participants]

“The current work complies with all relevant ethical regulations.”

Semaglutide is identified as once-weekly subcutaneous semaglutide 2.4 mg, with manufacturer (Novo Nordisk) implied. Dose and regimen are described. Statistical software is identified (SAS version 9.4). Other bench resources are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (semaglutide) is adequately identified, and statistical software is specified.

Evidence

“Patients were randomly assigned in a double-blind manner and 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo.”

MethodsFind in source

“All statistical analyses were performed with SAS software, version 9.4 TS1M5 (SAS Institute).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (semaglutide) is adequately identified, and statistical software is named.

Evidence

paraphrase[Abstract]

“A prespecified analysis of the SELECT trial revealed that patients assigned to once-weekly subcutaneous semaglutide 2.4 mg lost significantly more weight than those receiving placebo.”

“All statistical analyses were performed with SAS software, version 9.4 TS1M5 (SAS Institute).”

Statistical analysisFind in source

Statistical tests are named (ANCOVA, logistic regression). Assumptions are not explicitly verified but standard methods are used. Exact p-values are reported (e.g., 1.323762 × 10^-94). Effect sizes with confidence intervals are reported. Software is identified. Data presentation includes figures with error bars and per-group n. Mathematical plausibility checks were not performed due to large N and continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported.

Evidence

“Exact P values are 1.323762 × 10 −94 and 9.80035 × 10 −100 for a and b , respectively.”

Figure 1Find in source

“treatment difference −8.7%; 95% CI −9.42 to −7.88; P < 0.0001”

ResultsFind in source

“Continuous endpoints were analyzed using an analysis of covariance model with treatment as a fixed factor and baseline value of the endpoint as a covariate.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported.

Evidence

“Continuous endpoints were analyzed using an analysis of covariance model with treatment as a fixed factor and baseline value of the endpoint as a covariate.”

Statistical analysisFind in source

“Exact P values are 1.323762 × 10 −94 and 9.80035 × 10 −100 for a and b , respectively.”

Figure 1Find in source

“treatment difference −8.7%; 95% CI −9.42 to −7.88; P < 0.0001”

ResultsFind in source

The data availability statement provides a concrete route: data will be shared with bona fide researchers who submit a research proposal approved by an independent review board, with individual patient data shared in deidentified form. This is a managed-access mechanism, which is appropriate for patient-level data. No code is shared, but no bespoke code is mentioned.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data availability is adequately described with a concrete access route.

Evidence

“Data will be shared with bona fide researchers who submit a research proposal approved by the independent review board. Individual patient data will be shared in data sets in a deidentified and anonymized format. Information about data access request proposals can be found at https://www.novonordisk-trials.com/ .”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability is adequately described with a concrete access mechanism.

Evidence

Data availabilityFind in source

The trial is registered (NCT03574597). Limitations are discussed in the Discussion. Conclusions are proportional to the evidence. Funding and competing interests are disclosed. Reporting guideline is not explicitly mentioned, but the paper follows CONSORT-like reporting for a trial.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent: trial registration, limitations, and funding/COI are reported.

Evidence

“ClinicalTrials.gov identifier: NCT03574597 (https://clinicaltrials.gov/ct2/show/NCT03574597) .”

AbstractFind in source

“The SELECT study has some limitations. First, SELECT was not a primary prevention trial, and the data should not be extrapolated to all individuals with overweight and obesity to prevent major adverse CV events.”

Discussion ¶5Find in source

“D.H.R. declares having received consulting honoraria from Altimmune, Amgen, Biohaven, Boehringer Ingelheim, Calibrate, Carmot Therapeutics, CinRx, Eli Lilly, Epitomee, Gila Therapeutics, IFA Celtics, Novo Nordisk, Pfizer, Rhythm, Scientific Intake, Wondr Health and Zealand Pharma;”

Competing interests sectionFind in source

PASSReviewer 2· 90% conf

Reporting is transparent: trial registration, limitations, and funding/COI are reported.

Evidence

“ClinicalTrials.gov identifier: NCT03574597 (https://clinicaltrials.gov/ct2/show/NCT03574597) .”

AbstractFind in source

Discussion ¶5Find in source

paraphrase[Competing interests]

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 32 references by DOI: 23 verified — 9 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

3 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 3 minor suggestions below.

3 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the minor reporting gaps (randomization method not detailed, no explicit reporting guideline statement, assumptions not explicitly verified) as minor limitations, but they do not undermine the validity of the findings. No erratum or correction appears warranted based on the checks performed.

1.
MEDIUMreporting
Add an explicit statement in the Methods or Reporting Summary that the study adheres to the CONSORT reporting guideline.
Both reviewers noted the absence of an explicit reporting guideline statement, which is a standard expectation for trial reports.
2.
MEDIUMreporting
In the Methods, describe the randomization method (e.g., central randomization with a web-based system) or cite the primary publication where it is detailed.
The randomization method is not detailed in this paper, and both reviewers flagged this as a minor reporting gap.
3.
MEDIUMstatistics
Add a brief note in the Statistical analysis section on verification of statistical assumptions (e.g., normality) or state that robust methods were used.
Reviewer 1 flagged assumptions_verified as 'reported_but_inadequate'; explicitly addressing assumptions would strengthen the statistical reporting.
4.
LOWreporting
Clarify in the Methods or Discussion that the trial was powered for the primary cardiovascular outcome, and that this secondary analysis is exploratory.
Power analysis for secondary endpoints is not reported; clarifying the primary powering would preempt reader questions.
5.
LOWdata code
Consider sharing the statistical analysis code in a public repository (e.g., GitHub) to enhance reproducibility, even though data are controlled access.
Both reviewers suggested code sharing as an optional improvement; it would increase transparency.
6.
LOWcopyedit
In the Abstract, ensure the list of placebo values aligns with the semaglutide values (weight, WC, WHtR) — the sentence lists three semaglutide values but only two placebo values.
The copyedit pass flagged a potential formatting issue that could confuse readers.
7.
LOWcopyedit
In the Results, Safety and tolerability section, explicitly label the order of BMI categories for the SAE rates to ensure consistency with the text.
The copyedit pass noted that the order of BMI categories is not explicitly stated, which could lead to misinterpretation.

Full text (45,697 chars)Analyzed: Aug 16, 2026

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Read alongside

Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial.

Read full text (PMC)

DOI

10.1038/s41591-024-02996-7

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Record fingerprint

e808c1acd5f0ddeb9be1af2d7d34efdea21fa8fd2efad0317a1cd0cd78e29fba

Verify via API

Issued Aug 16, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

4.5 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Biggest issues

01Efficacy rests on an unvalidated surrogate endpoint
highOverreachreviewer-assessedFull detail
The primary efficacy claim is weight loss and anthropometric changes (waist circumference, waist-to-height ratio, BMI category), which are surrogate markers for clinical outcomes. The paper does not demonstrate target engagement at the tested dose (e.g., PK/PD) nor cite validated evidence linking these surrogates to hard clinical outcomes in this context. Although the SELECT trial showed a 20% reduction in MACE, this analysis focuses on weight and anthropometrics, not the hard outcome.
“At 208 weeks, semaglutide was associated with mean reduction in weight (−10.2%), waist circumference (−7.7 cm) and waist-to-height ratio (−6.9%) versus placebo (−1.5%, −1.3 cm and −1.0%, respectively; P < 0.0001 for all comparisons versus placebo).”
Find in source

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit3 minor suggestions

Numerical inconsistencies

None found

Checked — nothing surfaced.

Recomputed 4 tests: 4 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 3 via agent-written checks.

Overstated conclusions

1 finding · worst high

Efficacy rests on an unvalidated surrogate endpointAssessed

6 major claims checked against the paper's own evidence: all adequately supported.

Premise concern: surrogate not validated for clinical benefit.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior research on obesity, weight loss, and semaglutide, and logically links it to the study objectives.

Evidence

paraphrase[Introduction, paragraph 3]

IntroductionFind in source

Discussion ¶1Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research on obesity, weight loss, and semaglutide, and logically links it to the study objectives.

Evidence

paraphrase[Introduction, paragraph 2]

paraphrase[Introduction, paragraph 4]

paraphrase[Introduction, paragraph 2]

“Producing and sustaining durable and clinically significant weight loss with lifestyle intervention alone has been challenging.”

Sub-criteria

controlsADEQUATE

power analysisNOT REPORTED

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is rigorous: randomized, double-blind, placebo-controlled, with prespecified analyses and appropriate statistical methods.

Evidence

“Patients were randomly assigned in a double-blind manner and 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo.”

MethodsFind in source

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The study design is rigorous: randomized, double-blind, placebo-controlled, with prespecified analyses and appropriate statistical methods.

Evidence

“Patients were randomly assigned in a double-blind manner and 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“Missing data at the landmark visit, for example, week 104, were imputed using a multiple imputation model and done separately for each treatment arm and included baseline value as a covariate.”

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported: sex, age, BMI, race, and other demographics are described.

Evidence

“The SELECT study enrolled 17,604 patients (72.3% male) from 41 countries between October 2018 and March 2021, with a mean (s.d.) age of 61.6 (8.9) years and BMI of 33.3 (5.0) kg m − 2”

ResultsFind in source

PASSReviewer 2· 90% conf

Biological variables are well reported: sex, age, BMI, race, and other demographics are described.

Evidence

paraphrase[Results, Study population]

“The SELECT study enrolled 17,604 patients (72.3% male) from 41 countries between October 2018 and March 2021, with a mean (s.d.) age of 61.6 (8.9) years and BMI of 33.3 (5.0) kg m − 2.”

paraphrase[Results, Study population]

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approvals and informed consent are adequately reported.

Evidence

“The protocol for SELECT was approved by national and institutional regulatory and ethical authorities in each participating country.”

MethodsFind in source

“All patients provided written informed consent before beginning any trial-specific activity.”

MethodsFind in source

PASSReviewer 2· 90% conf

Ethical approvals and informed consent are adequately reported.

Evidence

“The protocol for SELECT was approved by national and institutional regulatory and ethical authorities in each participating country.”

MethodsFind in source

“All patients provided written informed consent before beginning any trial-specific activity.”

MethodsFind in source

paraphrase[Methods, Trial design and participants]

“The current work complies with all relevant ethical regulations.”

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (semaglutide) is adequately identified, and statistical software is specified.

Evidence

“Patients were randomly assigned in a double-blind manner and 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo.”

MethodsFind in source

“All statistical analyses were performed with SAS software, version 9.4 TS1M5 (SAS Institute).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (semaglutide) is adequately identified, and statistical software is named.

Evidence

paraphrase[Abstract]

“A prespecified analysis of the SELECT trial revealed that patients assigned to once-weekly subcutaneous semaglutide 2.4 mg lost significantly more weight than those receiving placebo.”

“All statistical analyses were performed with SAS software, version 9.4 TS1M5 (SAS Institute).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported.

Evidence

“Exact P values are 1.323762 × 10 −94 and 9.80035 × 10 −100 for a and b , respectively.”

Figure 1Find in source

“treatment difference −8.7%; 95% CI −9.42 to −7.88; P < 0.0001”

ResultsFind in source

“Continuous endpoints were analyzed using an analysis of covariance model with treatment as a fixed factor and baseline value of the endpoint as a covariate.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals reported.

Evidence

“Continuous endpoints were analyzed using an analysis of covariance model with treatment as a fixed factor and baseline value of the endpoint as a covariate.”

Statistical analysisFind in source

“Exact P values are 1.323762 × 10 −94 and 9.80035 × 10 −100 for a and b , respectively.”

Figure 1Find in source

“treatment difference −8.7%; 95% CI −9.42 to −7.88; P < 0.0001”

ResultsFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data availability is adequately described with a concrete access route.

Evidence

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data availability is adequately described with a concrete access mechanism.

Evidence

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent: trial registration, limitations, and funding/COI are reported.

Evidence

“ClinicalTrials.gov identifier: NCT03574597 (https://clinicaltrials.gov/ct2/show/NCT03574597) .”

AbstractFind in source

Discussion ¶5Find in source

Competing interests sectionFind in source

PASSReviewer 2· 90% conf

Reporting is transparent: trial registration, limitations, and funding/COI are reported.

Evidence

“ClinicalTrials.gov identifier: NCT03574597 (https://clinicaltrials.gov/ct2/show/NCT03574597) .”

AbstractFind in source

Discussion ¶5Find in source

paraphrase[Competing interests]

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 32 references by DOI: 23 verified — 9 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

3 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 3 minor suggestions below.

3 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
MEDIUMreporting
Add an explicit statement in the Methods or Reporting Summary that the study adheres to the CONSORT reporting guideline.
Both reviewers noted the absence of an explicit reporting guideline statement, which is a standard expectation for trial reports.
2.
MEDIUMreporting
In the Methods, describe the randomization method (e.g., central randomization with a web-based system) or cite the primary publication where it is detailed.
The randomization method is not detailed in this paper, and both reviewers flagged this as a minor reporting gap.
3.
MEDIUMstatistics
Add a brief note in the Statistical analysis section on verification of statistical assumptions (e.g., normality) or state that robust methods were used.
Reviewer 1 flagged assumptions_verified as 'reported_but_inadequate'; explicitly addressing assumptions would strengthen the statistical reporting.
4.
LOWreporting
Clarify in the Methods or Discussion that the trial was powered for the primary cardiovascular outcome, and that this secondary analysis is exploratory.
Power analysis for secondary endpoints is not reported; clarifying the primary powering would preempt reader questions.
5.
LOWdata code
Consider sharing the statistical analysis code in a public repository (e.g., GitHub) to enhance reproducibility, even though data are controlled access.
Both reviewers suggested code sharing as an optional improvement; it would increase transparency.
6.
LOWcopyedit
In the Abstract, ensure the list of placebo values aligns with the semaglutide values (weight, WC, WHtR) — the sentence lists three semaglutide values but only two placebo values.
The copyedit pass flagged a potential formatting issue that could confuse readers.
7.
LOWcopyedit
In the Results, Safety and tolerability section, explicitly label the order of BMI categories for the SAE rates to ensure consistency with the text.
The copyedit pass noted that the order of BMI categories is not explicitly stated, which could lead to misinterpretation.

Full text (45,697 chars)Analyzed: Aug 16, 2026