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

Purpose

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)

Conditions

  • Obesity With Diabetes
  • Overweight With Diabetes

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ribupatide: Dose 1 		Participants will receive Dose 1 of ribupatide once weekly.
  • Drug: Ribupatide
    SC Injection
    Other names:
    • KAI-9531
Experimental
Ribupatide: Dose 2 		Participants will receive Dose 2 of ribupatide once weekly.
  • Drug: Ribupatide
    SC Injection
    Other names:
    • KAI-9531
Experimental
Ribupatide: Dose 3 		Participants will receive Dose 3 of ribupatide once weekly.
  • Drug: Ribupatide
    SC Injection
    Other names:
    • KAI-9531
Experimental
Ribupatide: Dose 4 		Participants will receive Dose 4 of ribupatide once weekly.
  • Drug: Ribupatide
    SC Injection
    Other names:
    • KAI-9531
Placebo Comparator
Placebo 		Participants will receive placebo matched to ribupatide once weekly.
  • Drug: Placebo
    SC Injection

Recruiting Locations

Kailera Clinical Site
Cullman, Alabama 35055

Kailera Clinical Site
Phoenix, Arizona 85012

Kailera Clinical Site
Sun City, Arizona 85351

Kailera Clinical Site
Little Rock, Arkansas 72205

Kailera Clinical Site
Escondido, California 92025

Kailera Clinical Site
La Mesa, California 91942

Kailera Clinical Site
Montclair, California 91763

Kailera Clinical Site
Northridge, California 91325

Kailera Clinical Site
Oceanside, California 92058

Kailera Clinical Site
Toluca Lake, California 91602

Kailera Clinical Site
Stamford, Connecticut 06905

Kailera Clinical Site
Bradenton, Florida 34209

Kailera Clinical Site
Hollywood, Florida 33024

Kailera Clinical Site
Jupiter, Florida 33458

Kailera Clinical Site
Miami, Florida 33135

Kailera Clinical Site
Miami Lakes, Florida 33016

Kailera Clinical Site
Orange City, Florida 32763

Kailera Clinical Site
Orlando, Florida 32801

Kailera Clinical Site
Orlando, Florida 32803

Kailera Clinical Site
The Villages, Florida 32162

Kailera Clinical Site
Decatur, Georgia 30030

Kailera Clinical Site
Lilburn, Georgia 30047

Kailera Clinical Site
Marietta, Georgia 30060

Kailera Clinical Site
Riverdale, Georgia 30274

Kailera Clinical Site
Skokie, Illinois 60077

Kailera Clinical Site
Newton, Kansas 67114

Kailera Clinical Site
Shreveport, Louisiana 71105

Kailera Clinical Site
Annapolis, Maryland 21401

Kailera Clinical Site
Columbia, Maryland 21045

Kailera Clinical Site
Boston, Massachusetts 02115

Kailera Clinical Site
Farmington Hills, Michigan 48334

Kailera Clinical Site
Missoula, Montana 59804

Kailera Clinical Site
Lincoln, Nebraska 68516

Kailera Clinical Site
Las Vegas, Nevada 89148

Kailera Clinical Site
Albany, New York 12203

Kailera Clinical Site
Laurelton, New York 11413

Kailera Clinical Site
New York, New York 10016

Kailera Clinical Site
Greensboro, North Carolina 27405

Kailera Clinical Site
Monroe, North Carolina 28112

Kailera Clinical Site
Morehead City, North Carolina 28557

Kailera Clinical Site
Morrisville, North Carolina 27560

Kailera Clinical Site
Cleveland, Ohio 44122

Kailera Clinical Site
Chickasha, Oklahoma 73018

Kailera Clinical Site
East Greenwich, Rhode Island 02818

Kailera Clinical Site
Spartanburg, South Carolina 29303

Kailea Clinical Site
Memphis, Tennessee 38119

Kailera Clinical Site
Amarillo, Texas 79124

Kailera Clinical Site
Brownsville, Texas 78526

Kailera Clinical Site
DeSoto, Texas 75115

Kailera Clinical Site
El Paso, Texas 79902

Kailera Clinical Site
Farmers Branch, Texas 75234

Kailera Clinical Site
Kingwood, Texas 77345

Kailera Clinical Site
Plano, Texas 75093

Kailera Clinical Site
Tomball, Texas 77375

Kailera Clinical Site
Pleasant View, Utah 84404

Kailera Clinical Site
Salt Lake City, Utah 84117

Kailera Clinical Site
Manassas, Virginia 20110

Kailera Clinical Site
Richmond, Virginia 23236

Kailera Clinical Site
Seattle, Washington 98104

Kailera Clinical Site
Bayamón, Puerto Rico 00959

Kailera Clinical Site
Ponce, Puerto Rico 00716

Kailera Clinical Site
San Juan, Puerto Rico 00907

Kailera Clinical Site
San Juan, Puerto Rico 00909

Kailera Clinical Site
Vega Baja, Puerto Rico 693

More Details

Status
Recruiting
Sponsor
Kailera

Study Contact

Kailera Therapeutics, Inc.
1-781-317-0291
info-clinicalstudies@kailera.com