K9531-3103, KaiNETIC 1, KAI-9531 for Obesity Without Diabetes
Research type
Research Study
Full title
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 with Weight-Related Comorbidities Who Do Not Have Diabetes.
IRAS ID
1013441
Contact name
John Kaiser
Contact email
Sponsor organisation
Kailera Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this clinical research study is to look at whether an investigational medication called KAI-9531 (the “study drug”) supports weight loss when given to people living with overweight or obesity. “Investigational” means that KAI-9531 has not yet been approved for the treatment of obesity or overweight by health authorities. This study is a Phase 3 study, which includes large-scale testing in hundreds to thousands of participants. Its goal is to expand on the information already obtained from previous studies and provide an understanding of whether or not the study drug works, the benefits from it and its safety.
Overweight and obesity are complex, chronic (continue for a long time) health conditions that can be caused by several factors such as genetics, environment, hormones, or other medical conditions. Usually, a combination of nutrition, physical exercise, medical treatment options, and healthcare support can be used to help in the treatment of overweight and obesity. More recently the use of injections using glucagon-like peptide-1 (GLP-1) or GLP/GIP (glucose-dependent insulinotropic polypeptide) are being used for weight loss. The study drug is a type of medication that works similarly to 2 hormones, GLP-1 and GIP, that are involved in regulating appetite, fat storage, and blood sugar. This means this type of medication may help control appetite and fat storage and help regulate blood sugar which may support weight loss.
Participants will be in this study for about 84 weeks (about 1 year and 8 months). The study involves about 22 visits. Participants will be assigned randomly to a study group to receive either the study drug or a placebo. A placebo looks like the study drug but does not contain any active ingredients. Participants will take the study medication for about 76 weeks (about 1 year and 6 months).
About 1800 people will take part in this study worldwide.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
26/NE/0036
Date of REC Opinion
30 Mar 2026
REC opinion
Further Information Favourable Opinion