Oral KAI-7535 for weight loss in adults with overweight or obesity and at least one weight-related condition
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
This Phase 2 trial will test whether a once-daily oral medicine called KAI-7535 helps adults with overweight or obesity (and at least one weight-related condition) lose more weight than a placebo, and will also look at safety and effects in people with type 2 diabetes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kailera Industry-sponsored |
| Locations | 10 sites (Chandler, Arizona and 9 other locations) |
| Trial ID | NCT07497880 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives participants once-daily oral KAI-7535 or placebo and follows them for changes in body weight and safety. The primary outcome is percent change in body weight; additional outcomes include tolerability and other weight-related measures. Eligible adults without diabetes must have BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with at least one weight-related comorbidity, and a separate cohort enrolls adults with type 2 diabetes and BMI ≥27 kg/m2 on stable therapy. Participants attend visits at Kailera clinical sites for dosing and follow-up.
Who should consider this trial
Good fit: Adults with BMI ≥30 kg/m2, or BMI ≥27 kg/m2 with at least one weight-related comorbidity, and a separate group of adults with type 2 diabetes and BMI ≥27 kg/m2 who are on stable diabetes therapy are the intended participants.
Not a fit: People with laboratory-confirmed diabetes who are excluded from the non-diabetes cohort, those taking glucose-lowering medications in that cohort, or those with recent severe diabetic complications may not be suitable and thus unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, oral KAI-7535 could offer an effective pill option to reduce body weight and improve related health measures for adults with overweight or obesity.
How similar studies have performed: Other GLP-1 receptor agonists have produced substantial weight loss in prior trials, so the mechanism has shown success, but oral KAI-7535 itself is being tested in early-phase studies.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Chandler, Arizona and 9 other locations
- Kailera Clinical Site — Chandler, Arizona, United States (Recruiting)
- Kailera Clinical Site — Irvine, California, United States (Recruiting)
- Kailera Clinical Site — Lincoln, California, United States (Recruiting)
- Kailera Clinical Site — Northridge, California, United States (Recruiting)
- Kailera Clinical Site — Hamden, Connecticut, United States (Recruiting)
- Kailera Clinical Site — Jupiter, Florida, United States (Recruiting)
- Kailera Clinical Site — Decatur, Georgia, United States (Recruiting)
- Kailera Clinical Site — South Bend, Indiana, United States (Recruiting)
- Kailera Clinical Site — Kenner, Louisiana, United States (Recruiting)
- Kailera Clinical Site — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Kailera Therapeutics, Inc.
- Email: info-clinicalstudies@kailera.com
- Phone: 1-781-317-0291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.