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KAI-9531 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| KAI-9531: Dose 1 | EXPERIMENTAL | Participants will receive Dose 1 of KAI-9531 once weekly. |
| KAI-9531: Dose 2 | EXPERIMENTAL | Participants will receive Dose 2 of KAI-9531 once weekly. |
| KAI-9531: Dose 3 | EXPERIMENTAL | Participants will receive Dose 3 of KAI-9531 once weekly. |
| KAI-9531: Dose 4 | EXPERIMENTAL | Participants will receive Dose 4 of KAI-9531 once weekly. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to KAI-9531 once weekly. |
| KAI-9531: Abdomen Injection Site | EXPERIMENTAL | Participants will receive KAI-9531 as a SC injection into the abdomen on Day 1 of either Treatment Period 1, 2 or 3. |
| KAI-9531: Thigh Injection Site | EXPERIMENTAL | Participants will receive KAI-9531 as a SC injection into the thigh on Day 1 of either Treatment Period 1, 2 or 3. |
| KAI-9531: Upper Arm Injection Site | EXPERIMENTAL | Participants will receive KAI-9531 as a SC injection into the upper arm on Day 1 of either Treatment Period 1, 2 or 3. |
| Name | Type | Description |
|---|---|---|
| KAI-9531 | DRUG | SC Injection |
| Placebo | DRUG | SC Injection |
Key Inclusion Criteria: * BMI ≥35 kilograms per meter squared (kg/m\^2). * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months. Key Exclusion Criteria: * Current diagnosis or history of diabetes mellitus, including type 1 diabete...
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KAI-9531 is an investigational small molecule being developed for the treatment of obesity. It is also being studied in healthy volunteers to assess its bioavailability. The drug is administered once weekly and is currently in clinical development, with studies enrolling participants living with obesity who do not have diabetes.
KAI-9531 targets the GLP-1/GIP receptor. By acting on these receptors, which are involved in glucose metabolism and appetite regulation, the drug is being investigated as a potential treatment for obesity. This mechanism is being evaluated in clinical trials to determine its efficacy and safety.
KAI-9531 is being developed by Kailera Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating obesity. Kailera Therapeutics is publicly traded under the ticker symbol KLRA.
KAI-9531 is in Phase 2 clinical development. A Phase 1 study has been completed, and a Phase 2 trial is currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities. It is being studied for its potential use in treating obesity.
KAI-9531 has two clinical trials. NCT07044401 is a completed Phase 1 study in healthy volunteers, evaluating the effect of injection site on bioavailability. NCT07458269 is a recruiting Phase 2 trial in participants with obesity who do not have diabetes, assessing efficacy and safety of once-weekly dosing.
KAI-9531 is a distinct investigational small molecule targeting the GLP-1/GIP receptor. It is not the same as other marketed obesity drugs, as it is still in clinical development. Its unique profile is being studied to determine its potential role in obesity treatment.