Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Recruiting
Phase 2Interventional Study
ObesityOverweight
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
320 (estimated)
Sponsor
Kailera · Industry
Who this trial is looking for
This trial is looking for adults who are overweight or living with obesity. Participants will take a daily pill called KAI-7535 and their weight will be monitored compared to those taking a placebo.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesPancreatitis
You may be able to join if
I have a BMI of 30 or more
I have a BMI of 27 or more and a weight-related health issue
I have been diagnosed with hypertension, dyslipidemia, or similar conditions
I do not have diabetes
I am stable on my diabetes treatment for at least 3 months (if diabetic)
You may not be able to join if
I have a history of diabetic ketoacidosis in the past year
I have experienced severe low blood sugar in the past year
I have unstable weight over the last 3 months
I have a history of serious mental health disorders
I have a known problem with how my stomach empties
I have had chronic or acute pancreatitis
I started certain medications that can change my weight recently
I have uncontrolled high blood pressure
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.
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The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcome…
The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.
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Eligibility Criteria
Key Inclusion Criteria:
* For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following:
* Hypertension
* Dyslipidemia
* Obstructive sleep apnea
* Cardiovascular dise…
Key Inclusion Criteria:
* For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following:
* Hypertension
* Dyslipidemia
* Obstructive sleep apnea
* Cardiovascular disease
* For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m\^2 only:
* Diagnosis of type 2 diabetes mellitus
* On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening
Key Exclusion Criteria:
* For participants without diabetes:
* Laboratory evidence of diabetes
* Taking a concomitant medication for the indication of glycemic control
* For participants living with type 2 diabetes mellitus only:
* History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
* History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
* History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
* Started medications that may cause significant weight change within 3 months prior to screening, including 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 carcinoma
* 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 or other severe psychiatric disorder
* Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3 months prior to screening
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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