New weekly shot could help people with obesity shed pounds without diabetes
NCT ID NCT07458269
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study tests a new medicine called KAI-9531 (ribupatide) given as a weekly shot to help people with obesity lose weight. It includes 250 adults who have a BMI of 35 or higher and have tried to lose weight before without success. Participants will receive either the drug or a placebo, and researchers will measure how much weight they lose over 48 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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264 people
The number who actually took part.
- Started
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Mar 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * BMI ≥35 kilograms per meter squared (kg/m\^2). * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months. Key Exclusion Criteria: * Current diagnosis or history of diabetes mellitus, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma. * Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers. * 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 within 2 years prior to Screening. * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kailera Clinical Site
Mesa, Arizona, 85213, United States
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Kailera Clinical Site
Sun City West, Arizona, 85375, United States
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Kailera Clinical Site
Irvine, California, 92614, United States
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Kailera Clinical Site
Lake Forest, California, 92630, United States
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Kailera Clinical Site
Lomita, California, 90717, United States
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Kailera Clinical Site
Long Beach, California, 90815, United States
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Kailera Clinical Site
Montclair, California, 91763, United States
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Kailera Clinical Site
Rolling Hills Estates, California, 90274, United States
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Kailera Clinical Site
San Diego, California, 92103, United States
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Kailera Clinical Site
Santa Ana, California, 92704, United States
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Kailera Clinical Site
Van Nuys, California, 91405, United States
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Kailera Clinical Site
DeLand, Florida, 32720, United States
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Kailera Clinical Site
Orlando, Florida, 32801, United States
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Kailera Clinical Site
Orlando, Florida, 32803, United States
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Kailera Clinical Site
The Villages, Florida, 32162, United States
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Kailera Clinical Site
Decatur, Georgia, 30030, United States
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Kailera Clinical Site
Woodstock, Georgia, 30189, United States
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Kailera Clinical Site
Morton, Illinois, 61550, United States
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Kailera Clinical Site
Indianapolis, Indiana, 46254, United States
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Kailera Clinical Site
Louisville, Kentucky, 40213, United States
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Kailera Clinical Site
Rockville, Maryland, 20852, United States
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Kailera Clinical Site
St Louis, Missouri, 63141, United States
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Kailera Clinical Site
Lincoln, Nebraska, 68516, United States
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Kailera Clinical Site
Omaha, Nebraska, 68144, United States
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Kailera Clinical Site
East Syracuse, New York, 13057, United States
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Kailera Clinical Site
Greensboro, North Carolina, 27405, United States
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Kailera Clinical Site
Monroe, North Carolina, 28112, United States
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Kailera Clinical Site
Raleigh, North Carolina, 27612, United States
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Kailera Clinical Site
Greenville, South Carolina, 29607, United States
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Kailera Clinical Site
Myrtle Beach, South Carolina, 29572, United States
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Kailera Clinical Site
Knoxville, Tennessee, 37909, United States
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Kailera Clinical Site
Memphis, Tennessee, 38119, United States
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Kailera Clinical Site
Garland, Texas, 75043, United States
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Kailera Clinical Site
San Antonio, Texas, 78215, United States
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Kailera Clinical Site
Winchester, Virginia, 22601, United States
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