PASSReviewer 1· 85% conf
The study design is rigorous for a phase 1 trial, with clear randomization, blinding, and a pre-specified analysis population, though some elements like power analysis are not applicable for a first-in-human dose-escalation study.
Evidence
paraphrase[Methods, Trial design and oversight]
“Participants were randomized to include six LY3475766 participants and two placebo (0.9% sodium chloride) participants in each cohort.”direct quote[Methods, Trial design and oversight]
“We conducted a phase 1, multicenter, randomized, double-blind, single ascending dose, first-in-human study.”direct quote[Methods, Statistical analysis]
“Log-transformed values outside three standard deviations of the mean were considered outliers and excluded from the dataset.”PASSReviewer 2· 90% conf
The study design is rigorous for a phase 1 trial, with clear randomization, blinding, and pre-specified endpoints, though some details like power analysis are not applicable for a first-in-human dose-escalation study.
Evidence
direct quote[Methods, Trial design and oversight]
“We conducted a phase 1, multicenter, randomized, double-blind, single ascending dose, first-in-human study.”paraphrase[Methods, Study participants]
“Eligible participants were overtly healthy male or female adults 18–65 years of age, with a body mass index ≥18.5 to <40 kg m−2, fasting triglyceride level 135–499 mg dl−1, and fasting LDL-C level ≥70 mg dl−1.”direct quote[Methods, Statistical analysis]
“Log-transformed values outside three standard deviations of the mean were considered outliers and excluded from the dataset.”