New weekly shot could help people with obesity shed pounds without diabetes

NCT ID NCT07458269

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

264 people

The number who actually took part.

Started

Mar 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Kailera Clinical Site

    Mesa, Arizona, 85213, United States

  • Kailera Clinical Site

    Sun City West, Arizona, 85375, United States

  • Kailera Clinical Site

    Irvine, California, 92614, United States

  • Kailera Clinical Site

    Lake Forest, California, 92630, United States

  • Kailera Clinical Site

    Lomita, California, 90717, United States

  • Kailera Clinical Site

    Long Beach, California, 90815, United States

  • Kailera Clinical Site

    Montclair, California, 91763, United States

  • Kailera Clinical Site

    Rolling Hills Estates, California, 90274, United States

  • Kailera Clinical Site

    San Diego, California, 92103, United States

  • Kailera Clinical Site

    Santa Ana, California, 92704, United States

  • Kailera Clinical Site

    Van Nuys, California, 91405, United States

  • Kailera Clinical Site

    DeLand, Florida, 32720, United States

  • Kailera Clinical Site

    Orlando, Florida, 32801, United States

  • Kailera Clinical Site

    Orlando, Florida, 32803, United States

  • Kailera Clinical Site

    The Villages, Florida, 32162, United States

  • Kailera Clinical Site

    Decatur, Georgia, 30030, United States

  • Kailera Clinical Site

    Woodstock, Georgia, 30189, United States

  • Kailera Clinical Site

    Morton, Illinois, 61550, United States

  • Kailera Clinical Site

    Indianapolis, Indiana, 46254, United States

  • Kailera Clinical Site

    Louisville, Kentucky, 40213, United States

  • Kailera Clinical Site

    Rockville, Maryland, 20852, United States

  • Kailera Clinical Site

    St Louis, Missouri, 63141, United States

  • Kailera Clinical Site

    Lincoln, Nebraska, 68516, United States

  • Kailera Clinical Site

    Omaha, Nebraska, 68144, United States

  • Kailera Clinical Site

    East Syracuse, New York, 13057, United States

  • Kailera Clinical Site

    Greensboro, North Carolina, 27405, United States

  • Kailera Clinical Site

    Monroe, North Carolina, 28112, United States

  • Kailera Clinical Site

    Raleigh, North Carolina, 27612, United States

  • Kailera Clinical Site

    Greenville, South Carolina, 29607, United States

  • Kailera Clinical Site

    Myrtle Beach, South Carolina, 29572, United States

  • Kailera Clinical Site

    Knoxville, Tennessee, 37909, United States

  • Kailera Clinical Site

    Memphis, Tennessee, 38119, United States

  • Kailera Clinical Site

    Garland, Texas, 75043, United States

  • Kailera Clinical Site

    San Antonio, Texas, 78215, United States

  • Kailera Clinical Site

    Winchester, Virginia, 22601, United States

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