This was a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial conducted at 13 sites in China to evaluate the efficacy and safety of VCT220, a novel oral nonpeptide GLP-1 receptor agonist (GLP-1RA), for the treatment of overweight and obesity. Trial registration numbers reported were CTR20233978 and NCT06569355. The primary objective was to assess the percent change in body weight from baseline to week 16. Secondary objectives included evaluation of metabolic and cardiometabolic parameters and safety assessments.
Adults aged 18–75 years with either overweight (body mass index [BMI] 24–28 kg/m² plus at least one comorbidity) or obesity (BMI ≥ 28 kg/m²) were eligible for inclusion. A total of 250 participants were randomized in a 3:1 ratio to receive VCT220 or placebo. Baseline demographic and comorbidity details beyond age and BMI categories were not reported in the abstract.
Participants were randomized to once-daily oral VCT220 at one of the tested doses (80 mg, 120 mg, or 160 mg) with either a slow titration (ST) or fast titration (FT) strategy, or to matched placebo. All groups received lifestyle counselling in addition to study medication. The treatment duration reported in the trial was 16 weeks. Exact titration step schedules and timing were not detailed in the abstract.
The primary endpoint was the percentage change in body weight from baseline to week 16. Secondary assessments reported in the abstract included categorical weight-loss thresholds (for example, the proportion of participants achieving ≥5% weight loss) and changes in metabolic variables such as HbA1c, fasting insulin, and blood pressure. Safety assessments focused on adverse events (AEs), with characterization of severity and relationship to dose titration.
Two hundred fifty participants were randomized: 189 to VCT220 and 61 to placebo. At week 16, mean percent body-weight reductions in the VCT220 groups ranged from −5.75% for the 80 mg dose to −9.73% for the 160 mg dose with fast titration. By comparison, the placebo group had a mean weight change of −1.61%. The differences between each VCT220 dose group and placebo were statistically significant (all p < 0.001 as reported).
The proportion of participants achieving clinically relevant weight loss (≥5% from baseline) varied by dose and titration strategy. Reported proportions ranged from 55.4% in the 80 mg group up to 90.3% in the 160 mg slow-titration group, versus 13.1% in the placebo group.
Beyond reductions in body weight, treatment with VCT220 was associated with improvements in glycemic and cardiometabolic measures reported in the abstract. Observed benefits included reductions in HbA1c, decreases in fasting insulin, and lowering of blood pressure. The abstract does not provide numerical magnitudes, confidence intervals, or p values for these secondary outcomes in the summary.
Adverse events reported were primarily gastrointestinal in nature and were described as mostly mild to moderate. These symptoms were most frequent during the titration phase. Few participants discontinued treatment due to adverse events, indicating that discontinuations were uncommon. The abstract does not list specific event rates, serious adverse events, or laboratory-safety findings; those details were not reported in the summary provided.
In this 16-week phase II study, once-daily oral VCT220 produced rapid, dose-dependent, and clinically meaningful weight loss compared with placebo, along with improvements in glycemic and blood-pressure measures. The tolerability profile reported—predominantly mild-to-moderate gastrointestinal events during titration—was consistent with the GLP-1RA class. The authors conclude that these results support further global phase III trials to verify efficacy, characterize safety more fully, and evaluate potential broader cardiometabolic benefits.
The trial was funded by Chengdu Vincentage Pharma Co., Ltd. The conflict of interest statement indicated that the lead investigator (LNJ) served as principal investigator for the study funded by Chengdu Vincentage. Two coauthors (BL and ML) are full-time employees of Chengdu Vincentage, and BL is additionally a company stockholder. Other authors reported no disclosures in the abstract. Further financial and author-disclosure details beyond the summary were not provided in the abstract.