Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Kailera

Status and phase: Invitation-only; Phase 2

Conditions: Obesity

Treatments: Drug: Ribupatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07458269

K9531-2110

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• BMI ≥35 kilograms per meter squared (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, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma.
• 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 within 2 years prior to Screening.
• Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), 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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250 participants in 5 patient groups, including a placebo group

Ribupatide: Dose 1

Experimental group

Description:

Participants will receive Dose 1 of ribupatide once weekly.

Treatment:

Drug: Ribupatide

Ribupatide: Dose 2

Experimental group

Description:

Participants will receive Dose 2 of ribupatide once weekly.

Treatment:

Drug: Ribupatide

Ribupatide: Dose 3

Experimental group

Description:

Participants will receive Dose 3 of ribupatide once weekly.

Treatment:

Drug: Ribupatide

Ribupatide: Dose 4

Experimental group

Description:

Participants will receive Dose 4 of ribupatide once weekly.

Treatment:

Drug: Ribupatide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to ribupatide once weekly.

Treatment:

Drug: Placebo