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

Phase 3RecruitingNCT07284901

Kailera1,156 enrolled

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,156

Conditions

Obesity With Diabetes Overweight With Diabetes

Interventions

RibupatideDRUG

SC Injection

PlaceboDRUG

SC Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (167)

Outcomes

Primary Outcomes

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 Outcomes

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

Central Contacts

Kailera Therapeutics, Inc.

CONTACT

1-781-317-0291 info-clinicalstudies@kailera.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Kailera Clinical Site

Cullman, Alabama, United States

RECRUITING

Kailera Clinical Site

Phoenix, Arizona, United States

RECRUITING

Kailera Clinical Site

Sun City, Arizona, United States

RECRUITING

Kailera Clinical Site

Little Rock, Arkansas, United States

RECRUITING

Kailera Clinical Site

Escondido, California, United States

RECRUITING

Kailera Clinical Site

La Mesa, California, United States

RECRUITING

Kailera Clinical Site

Montclair, California, United States

RECRUITING

Kailera Clinical Site

Northridge, California, United States

RECRUITING

Kailera Clinical Site

Oceanside, California, United States

RECRUITING

Kailera Clinical Site

Toluca Lake, California, United States

RECRUITING

...and 157 more locations

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

Percentage of Participants with HbA1c <5.7%

Time frame: Baseline, Week 76

Change From Baseline in Diastolic Blood Pressure (DBP)

Time frame: Baseline, Week 76

Percent Change From Baseline in Fasting Total Cholesterol

Time frame: Baseline, Week 76

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

Time frame: Baseline, Week 76

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

Time frame: Baseline, Week 76

Percent Change From Baseline in Fasting Insulin

Time frame: Baseline, Week 76

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

Time frame: Baseline, Week 76

Change From Baseline in CoEQ Positive Mood Score

Time frame: Baseline, Week 76

Change From Baseline in CoEQ Craving for Sweets Score

Time frame: Baseline, Week 76

Change From Baseline in CoEQ Craving for Savory Food Score

Time frame: Baseline, Week 76

Change From Baseline in CoEQ Hunger Score

Time frame: Baseline, Week 76

Change From Baseline in CoEQ Satiety Score

Time frame: Baseline, Week 76

Change From Baseline in CoEQ Combined Score

Time frame: Baseline, Week 76

Change From Baseline in Food Noise Questionnaire (FNQ) Score

Time frame: Baseline, Week 76

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

Time frame: Day 1 up to Week 80

Number of Participants With Anti-drug Antibodies (ADAs)

Time frame: Up to Week 80

Number of Participants With Neutralizing Antibodies (Nabs)

Time frame: Up to Week 80

Plasma Concentrations of Ribupatide

Time frame: Up to Week 76