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.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,340 (estimated)
Sponsor
Kailera · Industry
Who this trial is looking for
This trial is looking for people who are overweight or living with obesity and have related health issues, but do not have diabetes. Participants will receive a weekly injection of ribupatide or a placebo to see how it affects their weight.
Are You a Good Fit for This Trial?
Rules you outDiabetesPancreatitis
You may be able to join if
I have a BMI of 30 or more or a BMI of 27 or more with health issues.
I have tried to lose weight through diet or exercise in the last 6 months without success.
You may not be able to join if
I have diabetes.
I have started certain medications in the last 3 months that could change my weight.
My weight has changed more than 5% in the 3 months before screening.
I have a family or personal history of certain thyroid cancer.
I have uncontrolled high blood pressure or unstable heart disease.
I have had pancreatitis.
I have a history of suicide attempts.
I have a serious mental health condition.
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 the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
1. hypertension,
2. dyslipidemia,
3. obstructive sleep apnea, or
4. cardiovascular (CV) disease.
* History of being unresponsive to at least 1 self-reported effort to lose we…
Inclusion Criteria:
* BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
1. hypertension,
2. dyslipidemia,
3. obstructive sleep apnea, or
4. cardiovascular (CV) disease.
* History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.
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, 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 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, GLP-1 receptor 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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