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June 7, 2026

1690-P: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032, a Novel Oral Nonpeptide GLP-1 Receptor Agonist: Single- and Multiple-Ascending Dose Studies in Chinese Adults

Key Points

This study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBI3032 in Chinese adults with varying weight statuses.
Conducted single-ascending dose (SAD) study with 40 healthy participants and multiple-ascending dose (MAD) study with 80 participants, both randomized to receive IBI3032 or placebo.
In the SAD study, participants received doses ranging from 0.3 to 6 mg while the MAD study involved daily administration over 4 weeks with dose titration.
The data was collected and analyzed for safety, tolerability, and weight changes.
IBI3032 had a favorable safety profile with mild gastrointestinal adverse events and no serious adverse effects reported.
Pharmacokinetic data showed dose-proportional increases in AUCinf and Cmax with a half-life of 43.1-52.8 hours.
In the MAD study, participants on 8 mg and 9 mg IBI3032 showed weight loss of -8.8% and -10.7% respectively, compared to -2.1% for those on placebo.

Abstract

Introduction and Objective: IBI3032, a novel, oral non-peptide GLP-1 agonist. This first-in-human study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of IBI3032, in Chinese adults with /without overweight or obesity. Methods: In the single-ascending dose (SAD) study (NCT07134127), 40 healthy participants (BMI 20 to 40 kg/m2) were enrolled across 4 cohorts. 8 participants each in cohort 1, 2, 4 were randomized in a 6:2 ratio to receive a single dose of IBI3032 (0.3-6 mg) or placebo (PBO). 16 participants in cohort 3 were randomized to 2 crossover sequences (under fasted and fed conditions) in an 8:8 ratio and administered IBI3032 3 mg or PBO in a 6:2 ratio. In the multiple-ascending dose (MAD) study (NCT07170319), 80 participants (BMI 24 to 40 kg/m2) were randomized into 5 cohorts (16 in each cohort), in a 12:4 ratio to receive 4 weeks of daily oral IBI3032 or PBO with dose titration to 5 different target doses. Data cutoff date was Dec 4, 2025. Results: In SAD study, IBI3032 was well-tolerated. The most common AEs were gastrointestinal, all mild in severity; no SAE occurred. The PK profile of IBI3032 demonstrated approximately dose-proportional increases in both AUCinf and Cmax, with a geometric mean t1/2 of 43.1-52.8 h (0.3-6 mg). The observed food effect on PK was not expected to result in a clinically meaningful effect on safety and efficacy. In the ongoing MAD study, as the data cutoff date, 32 participants were enrolled (mean baseline body weight was 78.1 kg). No serve TEAEs and SAE were reported. The percentage change in mean body weight from baseline to week 4 were -8.8% and-10.7% for participants receiving IBI3032 in the 8 mg and 9 mg cohort, respectively, compared with-2.1% for those receiving PBO. Conclusion: IBI3032 demonstrated a favourable safety, tolerability, and PK profile. Preliminary data showed significant body weight reductions with multiple doses, supporting the continued clinical development of IBI3032 as a novel oral GLP-1 agent. Disclosure H. Zhou: Consultant; Current; Innovent Biologics, Inc. Y. Wang: Consultant; Current; Innovent Biologics, Inc. Y. Guo: Consultant; Current; Innovent Biologics, Inc. F. Yang: None. Y. You: Employee; Current; Innovent Biologics, Inc. S. Zheng: Employee; Current; Innovent. Z. Liu: None. H. Deng: Employee; Current; Innovent Biologics, Inc. L. Pei: Employee; Current; Innovent Biologics, Inc. H. Han-Zhang: None. L. Qian: Employee; Current; Innovent Biologics, Inc. Funding Innovent Biologics, Inc.

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