Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,200 (estimated)
Sponsor
Kailera · Industry
Who this trial is looking for
This trial is looking for individuals living with obesity who have struggled to lose weight through diet and exercise. Participants will receive a weekly injection of ribupatide and will be compared to those receiving semaglutide or a placebo.
Are You a Good Fit for This Trial?
Must not be takingSemaglutideTirzepatideGLP-1 receptor agonistsGIPGlucagon receptor agonists
Rules you outDiabetesPancreatitisThyroid cancerHigh blood pressureMajor depression
You may be able to join if
I have a body mass index (BMI) of 35 or higher.
I have tried to lose weight with diet or exercise but did not succeed in the last 6 months.
You may not be able to join if
I have diabetes.
I have taken certain medications that can change my weight in the last 3 months.
My weight has changed by more than 5% in the last 3 months.
I have a family or personal history of certain types of thyroid cancer.
I have uncontrolled high blood pressure.
I have had pancreatitis.
I have experienced a suicide attempt in the past.
I have active major depression or another severe psychiatric disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* BMI ≥35 kilograms per square meter (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 diabetes mellitus.
* Started medicati…
Key Inclusion Criteria:
* BMI ≥35 kilograms per square meter (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 diabetes mellitus.
* 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, and phentermine.
* Unstable weight defined as self-reported change in body weight exceeding 5% within the 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.
* Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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