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Tests treatment safety and results for Obesity With Diabetes
Official title Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
ClinicalTrials.gov ID: NCT07284901
What this study is testing
What is Ribupatide?
Ribupatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity with diabetes.
Also referred to as KAI-9531.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cullman, Alabama, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Little Rock, Arkansas, United States
- Escondido, California, United States
- Montclair, California, United States
- Northridge, California, United States
- Oceanside, California, United States
- Toluca Lake, California, United States
- Stamford, Connecticut, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- The Villages, Florida, United States
- Lilburn, Georgia, United States
- Skokie, Illinois, United States
- Springfield, Illinois, United States
- Newton, Kansas, United States
- Shreveport, Louisiana, United States
+ 93 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cullman, Alabama, United States; Phoenix, Arizona, United States; Sun City, Arizona, United States; Little Rock, Arkansas, United States; Escondido, California, United States; Montclair, California, United States and 107 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.