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NCT Number: NCT07284875

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

The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo 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, San Nicolás de los Arroyos, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of the following:
  • hypertension,
  • dyslipidemia,
  • obstructive sleep apnea, or
  • cardiovascular (CV) disease.
  • History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.

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, or phentermine.
  • 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.

Treatment and study plan

Ribupatide

Drug

SC Injection

Other names: KAI-9531

Placebo

Drug

SC Injection

Primary outcomes

  1. Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Time frame: Baseline, Week 76

Secondary outcomes

  1. Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Time frame: Baseline, Week 76

  2. Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

    Time frame: Baseline, Week 76

  3. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 76

  4. Change From Baseline in Absolute 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. Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  12. Change From Baseline in BMI

    Time frame: Baseline, Week 76

  13. Change From Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 76

  14. Percent Change From Baseline in Total Cholesterol

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  17. Percent Change From Baseline in Fasting Insulin

    Time frame: Baseline, Week 76

  18. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  20. Change From Baseline in CoEQ Positive Mood Score

    Time frame: Baseline, Week 76

  21. Change From Baseline in CoEQ Craving for Sweets Score

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  23. Change From Baseline in CoEQ Hunger Score

    Time frame: Baseline, Week 76

  24. Change From Baseline in CoEQ Satiety Score

    Time frame: Baseline, Week 76

  25. Change From Baseline in CoEQ Combined Score

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

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

    Time frame: Day 1 up to Week 80

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

    Time frame: Up to Week 80

  29. Number of Participants With Neutralizing Antibodies (Nabs)

    Time frame: Up to Week 80

  30. 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, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Acronym: KaiNETIC-1

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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