A study testing whether an investigational medicine (KAI-9531) from Kailera can help with weight.

Who can join

Adults 18+, have obesity, BMI 35+.

What you take

KAI-9531, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.

How long it lasts

The full study runs about 2.3 years; your own time in it is usually shorter.

What you get

The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.

What this study is for

Full study title: Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do No.

Primary condition: Obesity.

Who can join, in detail

Key inclusion criteria

• BMI >=35 kilograms per square meter (kg/m^2).
• History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.

Key exclusion criteria

• Current diagnosis or history of diabetes mellitus.
• Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
• Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening.
• Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
• Uncontrolled hypertension or unstable cardiovascular disease.

Where this study is enrolling

This trial has 25 US sites across 19 states. Contact the site coordinator directly to start the screening process.

Timeline

Started enrolling: 2025-12-30. Expected completion: 2028-04-17. Last updated on ClinicalTrials.gov: 2026-04-30.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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