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Active, Not Recruiting

NCT Number: NCT07458269

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kailera Clinical Site, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ribupatide

Drug

SC Injection

Other names: KAI-9531

Placebo

Drug

SC Injection

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 48

    Time frame: Baseline, Week 48

Secondary outcomes

  1. Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight

    Time frame: Baseline, Week 48

  2. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 48

  3. Change From Baseline in Absolute Body Weight

    Time frame: Baseline, Week 48

  4. Change From Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 48

  5. Percent Change From Baseline in Fasting Triglycerides

    Time frame: Baseline, Week 48

  6. Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol

    Time frame: Baseline, Week 48

  7. Percent Change From Baseline in Fasting Non-HDL-cholesterol

    Time frame: Baseline, Week 48

  8. Percent Change From Baseline in Fasting Total Cholesterol

    Time frame: Baseline, Week 48

  9. Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol

    Time frame: Baseline, Week 48

  10. Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol

    Time frame: Baseline, Week 48

  11. Percent Change From Baseline in Fasting Insulin

    Time frame: Baseline, Week 48

  12. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline, Week 48

  13. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 up to Week 52

  14. Number of Participants With Anti-drug Antibodies (ADAs)

    Time frame: Day 1 up to Week 52

  15. Number of Participants With Neutralizing Antibodies (NAbs)

    Time frame: Day 1 up to Week 52

  16. Plasma Concentrations of Ribupatide

    Time frame: Day 1 up to Week 52

Sponsors and collaborators

Lead sponsor

Kailera

Industry

Registry information

Official study title

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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