MedTrace Logo

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

NCT07284901 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1700

Last updated 2026-05-20

No results posted yet for this study

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

DRUG

KAI-9531

SC Injection

DRUG

Placebo

SC Injection

Sponsors & Collaborators

  • Kailera

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2028-03-27
Completion
2028-04-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07284901 on ClinicalTrials.gov