KAI-7535 for Adults with Obesity or Overweight

Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

Recruiting Phase 2 Interventional Study
Obesity Overweight
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 – 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 out Type 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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About This Trial
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…
Trial Locations
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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…
Contacts

Kailera Therapeutics, Inc.

1-781-317-0291

info-clinicalstudies@kailera.com

CONTACT