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Recruiting NCT07284901

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

Phase III Interventional Obesity With Diabetes Overweight With Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ribupatide, Placebo.
Who it may be relevant to
Registry conditions: Obesity With Diabetes, Overweight With Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Bulgaria, Czechia +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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)

Interventions

  • Drug Ribupatide
    SC Injection
  • Drug Placebo
    SC Injection

Primary outcome measures

  • Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [Time frame: Baseline, Week 76]
  • Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76 [Time frame: Baseline, Week 76]
Secondary outcome measures (12)
  • Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [Time frame: Baseline, Week 76]
  • Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76 [Time frame: Baseline, Week 76]
  • Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight [Time frame: Baseline, Week 76]
  • Change From Baseline in Waist Circumference [Time frame: Baseline, Week 76]
  • Change From Baseline in Absolute Body Weight [Time frame: Baseline, Week 76]
  • Percentage of Participants with HbA1c <7% and ≤6.5% [Time frame: Baseline, Week 76]
  • Change From Baseline in Fasting Blood Glucose [Time frame: Baseline, Week 76]
  • Change From Baseline in Systolic Blood Pressure (SBP) [Time frame: Baseline, Week 76]
  • Percent Change From Baseline in Fasting Triglycerides [Time frame: Baseline, Week 76]
  • Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol [Time frame: Baseline, Week 76]
  • Percent Change From Baseline in Fasting Non-HDL-cholesterol [Time frame: Baseline, Week 76]
  • 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]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 41 centers
  • Kailera Clinical Site — Cullman
  • Kailera Clinical Site — Phoenix
  • Kailera Clinical Site — Sun City
  • Kailera Clinical Site — Little Rock
  • Kailera Clinical Site — Escondido
  • Kailera Clinical Site — Montclair
  • Kailera Clinical Site — Northridge
  • Kailera Clinical Site — Oceanside
  • … and 33 more centers
Australia · 12 centers
  • Kailera Clinical Site — Bruce
  • Kailera Clinical Site — Blacktown
  • Kailera Clinical Site — Kanwal
  • Kailera Clinical Site — Leichhardt
  • Kailera Clinical Site — Sydney
  • Kailera Clinical Site — Sydney
  • Kailera Clinical Site — Wollongong
  • Kailera Clinical Site — Herston
  • … and 4 more centers
Poland · 11 centers

Center list to be confirmed — check the primary protocol.

Argentina · 9 centers
  • Kailera Clinical Site — Ciudad Autonoma de Buenos Aires
  • Kailera Clinical Site — Mar del Plata
  • Kailera Clinical Site — San Nicolás de los Arroyos
  • Kailera Clinical Site — Zárate
  • Kailera Clinical Site — Buenos Aires
  • Kailera Clinical Site — Godoy Cruz
  • Kailera Clinical Site — Rosario
  • Kailera Clinical Site — CABA
  • … and 1 more center
Bulgaria · 9 centers
  • Kailera Clinical Site — Kyustendil
  • Kailera Clinical Site — Pleven
  • Kailera Clinical Site — Plovdiv
  • Kailera Clinical Site — Rousse
  • Kailera Clinical Site — Sofia
  • Kailera Clinical Site — Sofia
  • Kailera Clinical Site — Stara Zagora
  • Kailera Clinical Site — Varna
  • … and 1 more center
Czechia · 8 centers
  • Kailera Clinical Site — Brandýs nad Labem
  • Kailera Clinical Site — Náchod
  • Kailera Clinical Site — Trutnov
  • Kailera Clinical Site — Brno
  • Kailera Clinical Site — Holešov
  • Kailera Clinical Site — Hodonín
  • Kailera Clinical Site — Pardubice
  • Kailera Clinical Site — Uherské Hradiště
New Zealand · 8 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 8 centers

Center list to be confirmed — check the primary protocol.

Germany · 5 centers
  • Kailera Clinical Site — Falkensee
  • … and 4 more centers
Spain · 4 centers

Center list to be confirmed — check the primary protocol.

Puerto Rico · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07284901 · K9531-3104 · 2025-523510-87-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗