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

Recruiting · NCT07284901 · Interventional (participants receive a specific treatment) · Lead sponsor: Kailera

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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)

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 27 US states.

Kailera Clinical Site - Cullman, Alabama, United States
Kailera Clinical Site - Phoenix, Arizona, United States
Kailera Clinical Site - Sun City, Arizona, United States
Kailera Clinical Site - Little Rock, Arkansas, United States
Kailera Clinical Site - Escondido, California, United States
Kailera Clinical Site - La Mesa, California, United States
Kailera Clinical Site - Montclair, California, United States
Kailera Clinical Site - Northridge, California, United States
Kailera Clinical Site - Oceanside, California, United States
Kailera Clinical Site - Toluca Lake, California, United States
Kailera Clinical Site - Stamford, Connecticut, United States
Kailera Clinical Site - Bradenton, Florida, United States
Kailera Clinical Site - Hollywood, Florida, United States
Kailera Clinical Site - Jupiter, Florida, United States
Kailera Clinical Site - Miami, Florida, United States
Kailera Clinical Site - Miami Lakes, Florida, United States
Kailera Clinical Site - Orange City, Florida, United States
Kailera Clinical Site - Orlando, Florida, United States
Kailera Clinical Site - Orlando, Florida, United States
Kailera Clinical Site - The Villages, Florida, United States
Kailera Clinical Site - Decatur, Georgia, United States
Kailera Clinical Site - Lilburn, Georgia, United States
Kailera Clinical Site - Marietta, Georgia, United States
Kailera Clinical Site - Riverdale, Georgia, United States
Kailera Clinical Site - Skokie, Illinois, United States
Kailera Clinical Site - Springfield, Illinois, United States
Kailera Clinical Site - Newton, Kansas, United States
Kailera Clinical Site - Shreveport, Louisiana, United States
Kailera Clinical Site - Annapolis, Maryland, United States
Kailera Clinical Site - Columbia, Maryland, United States
Kailera Clinical Site - Boston, Massachusetts, United States
Kailera Clinical Site - Farmington Hills, Michigan, United States
Kailera Clinical Site - Missoula, Montana, United States
Kailera Clinical Site - Lincoln, Nebraska, United States
Kailera Clinical Site - Las Vegas, Nevada, United States
Kailera Clinical Site - Albany, New York, United States
Kailera Clinical Site - Laurelton, New York, United States
Kailera Clinical Site - New York, New York, United States
Kailera Clinical Site - Greensboro, North Carolina, United States
Kailera Clinical Site - Monroe, North Carolina, United States
Kailera Clinical Site - Morehead City, North Carolina, United States
Kailera Clinical Site - Morrisville, North Carolina, United States
Kailera Clinical Site - Cleveland, Ohio, United States
Kailera Clinical Site - Chickasha, Oklahoma, United States
Kailera Clinical Site - East Greenwich, Rhode Island, United States
Kailera Clinical Site - Spartanburg, South Carolina, United States
Kailera Clinical Site - Chattanooga, Tennessee, United States
Kailea Clinical Site - Memphis, Tennessee, United States
Kailera Clinical Site - Amarillo, Texas, United States
Kailera Clinical Site - Brownsville, Texas, United States
Kailera Clinical Site - DeSoto, Texas, United States
Kailera Clinical Site - El Paso, Texas, United States
Kailera Clinical Site - Farmers Branch, Texas, United States
Kailera Clinical Site - Kingwood, Texas, United States
Kailera Clinical Site - Plano, Texas, United States
Kailera Clinical Site - Tomball, Texas, United States
Kailera Clinical Site - Pleasant View, Utah, United States
Kailera Clinical Site - Salt Lake City, Utah, United States
Kailera Clinical Site - Manassas, Virginia, United States
Kailera Clinical Site - Richmond, Virginia, United States

Showing 60 of 167 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →