WARNReviewer 1· 85% conf
Sex is reported for some preclinical studies (e.g., NHP toxicology uses both sexes) and clinical trial (self-reported), but justification for single-sex studies is missing. Age, weight, species, strain, and source are well-reported for animal models. Demographics for the clinical trial are partially reported (age, sex, BMI) but race/ethnicity is omitted.
Evidence
direct quote[Results, paragraph 8 (preclinical), Extended Data Fig. 7]
“Dose-dependent reductions in plasma TG and TC were observed in TLC-2716-treated monkeys (Extended Data Fig. 7)... in CD-1 mice treated with... both sexes”absence[Table 1, Baseline characteristics]
Demographics for the clinical trial lack race/ethnicity.direct quote[Methods, animal studies]
“C57BL/6J mice, aged 8–10 weeks, were fed a high-fat diet (HFD, 60% kcal fat) for 12 weeks to induce obesity.”PASSReviewer 2· 90% conf
Biological variables are well-reported for both preclinical and clinical components, including sex, age, weight, species/strain, and human demographics.
Evidence
direct quote[Methods, Toxicity study, NHPs]
“A 4-week GLP toxicology study was conducted in cynomolgus monkeys... to evaluate the safety profile of TLC-2716 administered orally once daily at 1, 5 and 15 mg per kg (body weight) per day.”direct quote[Results, TLC-2716 was well tolerated...]
“At baseline, mean plasma TG was 102 ± 39 mg dl⁻¹ and LDL-C was 111 ± 30 mg dl⁻¹; TG ≥ 100 mg dl⁻¹, RC ≥ 20 mg dl⁻¹ and LDL-C ≥ 100 mg dl⁻¹ were observed in 23, 20 and 30 individuals, respectively (Table 1).”direct quote[Methods, Toxicity study, CD-1 mice]
“Animal housing facilities were maintained at 20–26 °C with 30–70% humidity. Mice were kept on a 12-h light/12-h dark cycle with ad libitum access to food and water.”FAILReviewer 3· 85% conf
Sex, age, weight, and housing conditions are not reported for most animal studies; the human trial reports demographics but animal data are incomplete.
Evidence
direct quote[Results, paragraph 2 and Figure 2 legends]
“c – f , Liver target engagement assessed by the expression of LXR target genes ( c ), liver TG content ( d ), plasma TG AUC ( e ) and plasma TC AUC ( f ) in HFD-DIO mice ( n = 6 per group), HFD-fed SD rats ( n = 6 per group) and HFD-fed ZDF rats ( n = 6 for vehicle and 5 for the treatment group) treated with TLC-2716; Ctrl, control.”direct quote[Results, paragraph 6 and Table 1]
“At baseline, mean plasma TG was 102 ± 39 mg dl−1 and LDL-C was 111 ± 30 mg dl−1; TG ≥ 100 mg dl−1, RC ≥ 20 mg dl−1 and LDL-C ≥ 100 mg dl−1 were observed in 23, 20 and 30 individuals, respectively (Table ).”direct quote[Methods, Toxicity study]
“Animal housing facilities were maintained at 20–26 °C with 30–70% humidity. Mice were kept on a 12-h light/12-h dark cycle with ad libitum access to food and water.”