Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07284901

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on:

* Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kailera Clinical Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus (T2DM).
  • Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
  • BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
  • History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
  • History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
  • 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 (GI) motility if taken for >30 days continually within 3 months prior to Screening.
  • 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, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise 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. Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Time frame: Baseline, Week 76

  2. Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

    Time frame: Baseline, Week 76

Secondary outcomes

  1. Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

    Time frame: Baseline, Week 76

  2. Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  4. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 76

  5. Change From Baseline in Absolute Body Weight

    Time frame: Baseline, Week 76

  6. Percentage of Participants with HbA1c <7% and ≤6.5%

    Time frame: Baseline, Week 76

  7. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  9. Percent Change From Baseline in Fasting Triglycerides

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  12. 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

  13. 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

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

    Time frame: Baseline, Week 76

  15. Change From Baseline in BMI

    Time frame: Baseline, Week 76

  16. Percentage of Participants with HbA1c <5.7%

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  18. Percent Change From Baseline in Fasting Total Cholesterol

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  21. Percent Change From Baseline in Fasting Insulin

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  23. Change From Baseline in CoEQ Positive Mood Score

    Time frame: Baseline, Week 76

  24. Change From Baseline in CoEQ Craving for Sweets Score

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

  26. Change From Baseline in CoEQ Hunger Score

    Time frame: Baseline, Week 76

  27. Change From Baseline in CoEQ Satiety Score

    Time frame: Baseline, Week 76

  28. Change From Baseline in CoEQ Combined Score

    Time frame: Baseline, Week 76

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

    Time frame: Baseline, Week 76

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

    Time frame: Day 1 up to Week 80

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

    Time frame: Up to Week 80

  32. Number of Participants With Neutralizing Antibodies (Nabs)

    Time frame: Up to Week 80

  33. 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]

1-781-317-0291

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 and Diabetes

Acronym: KaiNETIC-2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 16, 2025
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.

Published trials that share one or more normalized conditions with this study.