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
1,156 (estimated)
Sponsor
Kailera · Industry
Who this trial is looking for
This trial is looking for people with obesity or overweight who also have type 2 diabetes. Participants will receive a weekly injection of ribupatide to see how it affects their weight and blood sugar levels.
Are You a Good Fit for This Trial?
Must not be takingDPP-4 inhibitorsSemaglutideTirzepatide
Rules you outType 1 diabetesHypoglycemiaDiabetic ketoacidosisPancreatitis
You may be able to join if
I have been diagnosed with type 2 diabetes
I have a BMI of 27 or higher
I have tried to lose weight with diet and exercise in the last 6 months
I have been on a stable diabetes treatment for at least 3 months
You may not be able to join if
I have a history of type 1 diabetes
I have had severe low blood sugar or diabetic ketoacidosis in the past year
I have changed my weight by more than 5% in the past 3 months
I have a history of pancreatitis
I have uncontrolled high blood pressure
I have a history of suicidal behavior
I have been diagnosed with a severe psychiatric disorder in the last 2 years
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 placebo on:
* Percent change in body weight
* Change in hemoglobin A1c (HbA1c)
Trial Locations
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Eligibility Criteria
Key Inclusion 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 treatm…
Key Inclusion 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 treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
* 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 Exclusion Criteria:
* 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 aside from diet and exercise within 3 months prior to Screening.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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