What question did this study set out to answer?

This analysis aimed to evaluate the glucose-lowering effects of zovaglutide in adults with prediabetes who are overweight or obese.

June 7, 2026

1725-P: Once-Monthly Zovaglutide (ZT002) in Adults with Overweight or Obesity and Prediabetes: A Phase 2 Subgroup Analysis

Key Points

This analysis aimed to evaluate the glucose-lowering effects of zovaglutide in adults with prediabetes who are overweight or obese.
Multicenter, randomized, double-blind, placebo-controlled trial.
Participants with overweight or obesity and prediabetes were randomized to receive zovaglutide or placebo for 24 weeks.
Primary outcome was the proportion who transitioned to HbA1c <5.7%.
93.5%, 96.4%, 90.5%, and 100.0% of zovaglutide groups achieved HbA1c <5.7% compared to 22.2% in placebo group.
Weight loss of -10.8%, -12.8%, -12.9%, and -12.8% in zovaglutide groups versus -0.8% in placebo, all p < 0.0001.
Adverse events were mild to moderate and didn't lead to treatment discontinuation.

Abstract

Introduction and Objective: Zovaglutide, a once-monthly GLP-1 receptor agonist, has shown clinically meaningful weight loss with a favorable safety profile in participants with overweight or obesity in 24 weeks in a phase 2 study. This analysis was to explore the glucose-lowering effect of zovaglutide in prediabetes subgroup. Methods: A multicenter, randomized, double-blind, placebo-controlled, phase 2 study was conducted in adults with overweight (24 kg/m2≤BMI28 kg/m2) with at least one co-morbidity or obesity (BMI≥28 kg/m2) but without diabetes. Participants were randomized (3:3:2:2:2) to receive zovaglutide 80 mg or 160 mg once every 4 weeks (Q4W), zovaglutide 80 mg or 160 mg once every 2 weeks (Q2W), or matched placebo for 24 weeks. The prediabetes subgroup was defined as participants with HbA1c≥5.7% at baseline and with available HbA1c value at week 24. The primary outcome was the proportion of participants who transitioned to an HbA1c level5.7% (below the diagnostic threshold for prediabetes) at week 24. Results: Among the 303 participants randomized, 116 participants met the definition of prediabetes subgroup. The subgroup baseline characteristics were generally balanced across all treatment groups, of which 48.3% were female, mean age was 33.4 years, mean BMI was 35.3 kg/m2 and mean HbA1c was 5.9%. The proportions of participants achieved HbA1c5.7% at week 24 in zovaglutide 80 mg Q4W group, 160 mg Q4W group, 80 mg Q2W group and 160 mg Q2W group were greater than in placebo group (93.5%, 96.4%, 90.5% and 100.0% vs. 22.2%). The percentage changes from baseline in weight in zovaglutide groups at week 24 were significantly greater than in placebo group (-10.8%, -12.8%, -12.9% and -12.8% vs. -0.8%, all p values0.0001). The most common adverse events were gastrointestinal and mostly were mild to moderate in severity. No adverse events led to treatment discontinuation. Conclusion: Once-monthly zovaglutide normalized glucose levels in participants with prediabetes and overweight or obesity over 24 weeks. Disclosure L. Ji: None. L. Gao: None. X. Zou: None. J. Zhang: None. H. Jiang: Consultant; Current; Innovent Biologics. Z. Cheng: None. D. Liu: None. J. Tian: None. K. Wang: None. H. Shu: None. X. Dong: None. L. Liu: None. X. Song: None. R. Zhao: None. X. Zhang: None. Y. Zhang: None.

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