KAI-9531 for Obesity

Recruiting at 31 trial locations

Overseen By Kailera Therapeutics, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kailera

Must not be taking: Tricyclics, Atypical antipsychotics, Mood stabilizers, GLP-1R agonists

Disqualifiers: Diabetes, Uncontrolled hypertension, Pancreatitis, MDD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

My BMI is 35 or higher.

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

Exclusion Criteria

I have used GLP-1 or similar diabetes medications in the past 3 months.

History of suicide attempt

I have had major depression or another severe mental illness in the past 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KAI-9531 or placebo by subcutaneous injection once weekly

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KAI-9531

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