What question did this study set out to answer?

To evaluate the safety, tolerability, and pharmacokinetics of KAI-9531 in participants with overweight/obesity.

June 7, 2026

2648-P: A Phase 1, Randomized, Double-Blind, Single-Ascending Dose Study of KAI-9531, a Novel Dual GLP-1/GIP Receptor Agonist in Development for People Living with Overweight/Obesity

Key Points

To evaluate the safety, tolerability, and pharmacokinetics of KAI-9531 in participants with overweight/obesity.
Randomized, double-blind, placebo-controlled, single-ascending dose study
49 participants (BMI 22.6-34.0 kg/m2) received KAI-9531 or placebo
Followed for 29 days to determine weight loss and pharmacokinetic differences.
KAI-9531 showed a dose-dependent reduction in body weight: 1 mg -1.4%, 2 mg non-Asian -2.8%, 2 mg Asian -2.1%, 3 mg -5.5%, placebo -0.4%.
No serious adverse events reported; common mild adverse events included decreased appetite (69.2%) and nausea (61.5%).
Systemic exposure to KAI-9531 was similar in Asian and non-Asian participants after adjusting for baseline weight.

Abstract

Introduction and Objective: KAI-9531 treatment led to promising weight loss in clinical trials of participants with overweight/obesity in China. This Phase 1 study was conducted to determine the safety/tolerability, pharmacokinetics (PK) and pharmacodynamics of a single dose of KAI-9531, and to evaluate any PK differences between Asian and non-Asian participants. Methods: In this randomized, double-blind, placebo (PBO)-controlled, single-ascending dose study, 49 participants (BMI range 22.6-34.0 kg/m2) received a single SC dose of KAI-9531 (n=39: 1 mg, 2 mg, or 3 mg) or PBO (n=10) and were followed for 29 days to end of study (EOS). Ten participants were of Asian heritage: 8 in a 2 mg cohort and 2 in the PBO cohort. The effect of Asian heritage on KAI-9531 PK was evaluated using a population PK model. Results: At baseline, mean (SD) age was 31.4 (9.95) years, BMI was 27.6 (3.42) kg/m2 and body weight (BW) was 79.9 (13.80) kg; 55% were female. Most TEAEs were mild in severity. No SAEs, TEAEs leading to study discontinuation, or severe TEAEs occurred. Most common TEAEs in the KAI-9531 group were decreased appetite (69.2%), nausea (61.5%), and vomiting (35.9%). Peak (Cmax) and systemic (AUC) exposures in Asian and non-Asian participants were similar when adjusted for baseline BW. Asian heritage was not a significant covariate for KAI-9531 PK. Mean (SD) percentage change in BW from baseline to EOS in each cohort was: 1 mg, −1.4% (1.6%); 2 mg non-Asian, −2.8% (2%); 2 mg Asian, −2.1% (1.8%); 3 mg, −5.5% (2.2%); PBO, −0.4% (2.1%). Greater reductions in fasting glucose, fasting insulin, and HbA1c were observed with KAI-9531 vs PBO. Conclusion: KAI-9531 was generally well tolerated after a single dose without titration, both in participants of Asian and non-Asian heritage. Similar exposure to KAI-9531 was observed between the two groups once adjusted for baseline BW. By EOS, KAI-9531 reduced BW both dose-dependently and compared with PBO, with no differences observed between Asian and non-Asian participants. Disclosure L. Klickstein: Employee; Ended; Eli Lilly and Company. A.M. Clark: Employee; Current; Kailera Therapeutics. C.S. Djedjos: Employee; Current; Kailera Therapeutics. A. Fernald: None. H. Zhang: None. S. Wasserman: Employee; Current; Kailera Therapeutics. A.C. Moses: Consultant; Current; Virta Health Corp., Vertex Pharmaceuticals Incorporated, Novo Nordisk A/S. Advisory Panel; Current; TixiMed. Stock/Shareholder; Current; Minutia. Advisory Panel; Current; Kailera, Metabolics Pharma. Consultant; Current; 3D Communication.

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