Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

NCT07284979 · Recruiting

Last updated 2026-05-28

This clinical trial is testing the effects of a new medication called KAI-9531, taken once a week, compared to semaglutide and a placebo in adults living with obesity who do not have diabetes.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 1,200 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2025-12 · est. completion 2028-04

Where 32 sites · Australia, United States

What this study is testing ClinicalTrials.gov NCT07284979 ↗

Description as written by the study sponsor.

The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Treatments tested

KAI-9531 Drug

SC Injection
Semaglutide also known as Wegovy Drug

SC Injection
Placebo Drug

SC Injection

Main thing measured	Percent Change From Baseline in Body Weight at Week 76
Sponsor	Kailera
Conditions studied	Obesity
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07284979 ↗