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NCT Number: NCT07284979

Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kailera Clinical Site, Bruce, Australian Capital Territory, Australia

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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 square meter (kg/m^2).
  • History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.

Key Exclusion Criteria:

  • Current diagnosis or history of diabetes mellitus.
  • Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, and phentermine.
  • Unstable weight defined as self-reported change in body weight exceeding 5% within the 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, glucagon-like peptide-1 receptor (GLP-1R) 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.

Treatment and study plan

Ribupatide

Drug

SC Injection

Other names: KAI-9531

semaglutide

Drug

SC Injection

Other names: Wegovy

Placebo

Drug

SC Injection

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 76

    Time frame: Baseline, Week 76

Secondary outcomes

  1. Percentage of Participants with ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

    Time frame: Baseline, Week 76

  2. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 76

  3. Change From Baseline in Absolute Body Weight

    Time frame: Baseline, Week 76

  4. Percentage of Participants with ≥5% Reduction in Body Weight

    Time frame: Baseline, Week 76

  5. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 76

  6. Percent Change From Baseline in Fasting Triglycerides

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  9. Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

    Time frame: Baseline, Week 76

  10. Percentage of Participants with ≥30% Reduction in Body Weight

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  12. Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score

    Time frame: Baseline, Week 76

  13. Change From Baseline in CoEQ Positive Mood Score

    Time frame: Baseline, Week 76

  14. Change From Baseline in CoEQ Craving for Sweets Score

    Time frame: Baseline, Week 76

  15. Change From Baseline in CoEQ Craving for Savory Food Score

    Time frame: Baseline, Week 76

  16. Change From Baseline in CoEQ Hunger Score

    Time frame: Baseline, Week 76

  17. Change From Baseline in CoEQ Satiety Score

    Time frame: Baseline, Week 76

  18. Change From Baseline in CoEQ Combined Score

    Time frame: Baseline, Week 76

  19. Change From Baseline in Food Noise Questionnaire (FNQ) Score

    Time frame: Baseline, Week 76

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

    Time frame: Day 1 up to Week 80

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

    Time frame: Up to Week 80

  22. Number of Participants With Neutralizing Antibodies (Nabs)

    Time frame: Up to Week 80

  23. Plasma Concentrations of Ribupatide

    Time frame: Up to Week 76

Study contacts

Contact information is provided by the study sponsor or research team.

Kailera Therapeutics, Inc.

CONTACT

[email protected]

781-317-0291

Sponsors and collaborators

Lead sponsor

Kailera

Industry

Registry information

Official study title

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Acronym: KaiNETIC-3

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 16, 2025
Registry last updated
Jul 22, 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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