Recruiting NCT07284875

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

Phase III Interventional Obesity Overweight

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, Overweight. 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 +5
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 With Weight-Related Comorbidities Who Do Not Have Diabetes

Overview

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.

Interventions

Drug Ribupatide
SC Injection
Drug Placebo
SC Injection

Primary outcome measures

Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [Time frame: Baseline, Week 76]

Secondary outcome measures (12)

Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight 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]
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]
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]
Percentage of Participants with ≥30% Reduction in Body Weight [Time frame: Baseline, Week 76]
Change From Baseline in BMI [Time frame: Baseline, Week 76]

Eligibility criteria

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.

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 · 24 centers

Kailera Clinical Site — Anniston
Kailera Clinical Site — Birmingham
Kailera Clinical Site — Cullman
Kailera Clinical Site — Sun City
Kailera Clinical Site — Escondido
Kailera Clinical Site — Toluca Lake
Kailera Clinical Site — Aurora
Kailera Clinical Site — Bridgeport
… and 16 more centers

Australia · 10 centers

Kailera Clinical Site — Silverdale
Kailera Clinical Site — Charlestown
Kailera Clinical Site — Sydney
Kailera Clinical Site — Sydney
Kailera Clinical Site — Sydney
Kailera Clinical Site — Wollongong
Kailera Clinical Site — Sippy Downs
Kailera Clinical Site — Norwood
… and 2 more centers

Germany · 9 centers

Kailera Clinical Site — Falkensee
Kailera Clinical Site — Cologne
Kailera Clinical Site — Essen
Kailera Clinical Site — Dresden
Kailera Clinical Site — Leipzig
Kailera Clinical Site — Oldenburg in Holstein
Kailera Clinical Site — Hamburg
Kailera Clinical Site — Hamburg
… and 1 more center

Argentina · 8 centers

Kailera Clinical Site — San Nicolás de los Arroyos
Kailera Clinical Site — Buenos Aires
Kailera Clinical Site — Buenos Aires
Kailera Clinical Site — Buenos Aires
Kailera Clinical Site — Godoy Cruz
Kailera Clinical Site — Rosario
Kailera Clinical Site — CABA
Kailera Clinical Site — Córdoba

Bulgaria · 8 centers

Kailera Clinical Site — Kyustendil
Kailera Clinical Site — Pazardzhik
Kailera Clinical Site — Plovdiv
Kailera Clinical Site — Plovdiv
Kailera Clinical Site — Sofia
Kailera Clinical Site — Sofia
Kailera Clinical Site — Varna
Kailera Clinical Site — Yambol

United Kingdom · 8 centers

Center list to be confirmed — check the primary protocol.

Poland · 6 centers

Kailera Clinical Site — Torun
Kailera Clinical Site — Krakow
Kailera Clinical Site — Siedlce
Kailera Clinical Site — Warsaw
Kailera Clinical Site — Skierniewice
Kailera Clinical Site — Zamość

Spain · 6 centers

Kailera Clinical Site — Ferrol
Kailera Clinical Site — Villamartín
Kailera Clinical Site — Castilleja de la Cuesta
Kailera Clinical Site — Barcelona
Kailera Clinical Site — Madrid
Kailera Clinical Site — Valencia

Czechia · 5 centers

Kailera Clinical Site — Brandýs nad Labem
Kailera Clinical Site — Náchod
Kailera Clinical Site — Brno
Kailera Clinical Site — Hodonín
Kailera Clinical Site — Uherské Hradiště

New Zealand · 4 centers

Kailera Clinical Site — Grafton
Kailera Clinical Site — Hamilton
Kailera Clinical Site — Auckland
Kailera Clinical Site — Nelson

Identifiers

NCT: NCT07284875 · K9531-3103 · 2025-523486-17-00

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗