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KAI-7535 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| KAI-7535: Dose Schedule 1 | EXPERIMENTAL | Participants will receive KAI-7535 once daily. |
| KAI-7535: Dose Schedule 2 | EXPERIMENTAL | Participants will receive KAI-7535 once daily. |
| KAI-7535: Dose Schedule 3 | EXPERIMENTAL | Participants will receive KAI-7535 once daily. |
| KAI-7535: Dose Schedule 4 | EXPERIMENTAL | Participants will receive KAI-7535 once daily. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to KAI-7535 once daily. |
| KAI-7535: Morning Dosing, Fed | EXPERIMENTAL | Participants will receive KAI-7535 in the morning following a meal on dosing days. |
| KAI-7535: Morning Dosing, Fasted | EXPERIMENTAL | Participants will receive KAI-7535 in the morning following an overnight fast on dosing days. |
| KAI-7535: Evening Dosing | EXPERIMENTAL | Participants will receive KAI-7535 in the evening on dosing days. |
| Name | Type | Description |
|---|---|---|
| KAI-7535 | DRUG | Oral tablets |
| Placebo | DRUG | Oral tablets |
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...
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KAI-7535 is an investigational oral small molecule being developed for obesity and overweight. It is studied in adults living with obesity or overweight, including those with at least one weight-related comorbidity. The drug is in clinical development and has not been approved by the FDA.
KAI-7535 targets the GLP-1 receptor, a receptor involved in metabolic regulation. By acting on this receptor, the drug is being studied for its potential effects on weight management in people with obesity or overweight. It is administered orally as a small molecule.
KAI-7535 is being developed by Kailera Therapeutics, Inc., a biopharmaceutical company. The company's ticker symbol is KLRA. Kailera is conducting clinical trials to evaluate the safety and efficacy of KAI-7535 in participants with obesity or overweight.
KAI-7535 is currently in Phase 2 clinical development. A Phase 2 trial is recruiting participants to evaluate the efficacy and safety of oral KAI-7535 in adults with obesity or overweight who have at least one weight-related comorbidity. The drug is investigational and not yet approved.
KAI-7535 has two clinical trials. NCT07497880 is a Phase 2, randomized, double-blind, controlled study in adults with obesity or overweight and at least one comorbidity, recruiting 320 participants in the US and Australia. NCT07294898 is a completed Phase 1 study of 18 participants examining the effect of a low-fat meal and evening dosing.
KAI-7535 is the sole name provided for this investigational drug. No alternative names have been reported. It is a distinct small molecule being developed by Kailera Therapeutics for obesity and overweight, and it is not known to be identical to any other marketed or investigational agent.