Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Kailera

Status and phase: Enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: KAI-9531; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07284875

K9531-3103

2025-523486-17-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of the following:

  1. hypertension,
  2. dyslipidemia,
  3. obstructive sleep apnea, or
  4. cardiovascular (CV) disease.

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

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 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.
• History of chronic or acute pancreatitis.
• Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility.
• History of suicide attempt.
• History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.
• Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,800 participants in 5 patient groups, including a placebo group

KAI-9531: Dose 1

Experimental group

Description:

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

Treatment:

Drug: KAI-9531

KAI-9531: Dose 2

Experimental group

Description:

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

Treatment:

Drug: KAI-9531

KAI-9531: Dose 3

Experimental group

Description:

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

Treatment:

Drug: KAI-9531

KAI-9531: Dose 4

Experimental group

Description:

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

Treatment:

Drug: KAI-9531

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo