KAI-9531 for Obesity

Recruiting at 7 trial locations

Overseen By Kailera Therapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kailera

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Are You a Good Fit for This Trial?

This trial is for adults who are living with obesity or overweight and have related health issues like high blood pressure, abnormal cholesterol levels, sleep apnea, or heart disease. They should have tried to lose weight unsuccessfully in the past 6 months through diet and exercise.

Inclusion Criteria

History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months

My BMI is over 30, or it's over 27 and I have a condition like high blood pressure, cholesterol issues, sleep apnea, or heart disease.

Exclusion Criteria

I started taking medication that can cause weight gain within the last 3 months.

I have diabetes.

Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening

What Are the Treatments Tested in This Trial?

Interventions

• KAI-9531

Trial Overview

The study tests KAI-9531 injections against a placebo to see which is better at reducing body weight percentage. Participants will receive either the real medication or a placebo once weekly via subcutaneous injection.

How Is the Trial Designed?

Group I: KAI-9531: Dose 4 Experimental Treatment 1 Intervention

Participants will receive Dose 4 of KAI-9531 once weekly.

Group II: KAI-9531: Dose 3 Experimental Treatment 1 Intervention

Participants will receive Dose 3 of KAI-9531 once weekly.

Group III: KAI-9531: Dose 2 Experimental Treatment 1 Intervention

Participants will receive Dose 2 of KAI-9531 once weekly.

Group IV: KAI-9531: Dose 1 Experimental Treatment 1 Intervention

Participants will receive Dose 1 of KAI-9531 once weekly.

Group V: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to KAI-9531 once weekly.

Who Is Running the Clinical Trial?

Kailera

Lead Sponsor