NCT07284901

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,700 (estimated)
• Sponsor: Kailera · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Conditions

• Obesity With Diabetes
• Overweight With Diabetes

Interventions

Type	Name	Description
DRUG	KAI-9531	SC Injection
DRUG	Placebo	SC Injection

Timeline

• Start date: 2026-01-12
• Primary completion: 2028-03-27
• Completion: 2028-04-24
• First posted: 2025-12-16
• Last updated: 2026-04-09

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study