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This is a Phase 2a multicenter, randomized, double-blind, placebo-controlled clinical trial studying the efficacy, safety, and tolerability of orally administered TERN-601 in adults with overweight or obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TERN-601 Dose 1 | Experimental | Orally administered once daily. |
|
| TERN-601 Dose 2 | Experimental | Orally administered once daily. |
|
| TERN-601 Dose 3 | Experimental | Orally administered once daily. |
|
| TERN-601 Dose 4 | Experimental | Orally administered once daily. |
|
| Matching Placebo | Placebo Comparator | Orally administered once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TERN-601 | Drug | Investigational drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight | Percent change (%) in body weight from baseline to Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in body weight (kg) from baseline to Week 12 | 12 weeks |
| ≥ 5% Weight Loss | Proportion of participants achieving ≥ 5% weight loss |
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Key Inclusion Criteria:
Female or male aged 18 to 75 years
Body mass index (BMI) of:
≥ 30 kg/m^2 to < 50 kg/m^2
OR
≥ 27 kg/m^2 to < 30 kg/m^2 with at least 1 weight-related comorbidity
HbA1c < 6.5%
Stable self-reported body weight for at least 3 months prior to study (< 5% body weight gain or loss)
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FALCON Research Site | Birmingham | Alabama | 35294 | United States | ||
| FALCON Research Site |
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| Matching Placebo | Other | Matching placebo |
|
| 12 weeks |
| Homewood |
| Alabama |
| 35209 |
| United States |
| FALCON Research Site | Tucson | Arizona | 85712 | United States |
| FALCON Research Site | Spring Valley | California | 91978 | United States |
| FALCON Research Site | Port Orange | Florida | 32127 | United States |
| FALCON Research Site | Louisville | Kentucky | 40213 | United States |
| FALCON Research Site | Marrero | Louisiana | 70072 | United States |
| FALCON Research Site | Boston | Massachusetts | 02114 | United States |
| FALCON Research Site | Rochester | Minnesota | 55905 | United States |
| FALCON Research Site | City of Saint Peters | Missouri | 63303 | United States |
| FALCON Research Site | Beachwood | Ohio | 44122 | United States |
| FALCON Research Site | Medford | Oregon | 97504 | United States |
| FALCON Research Site | Dallas | Texas | 75230 | United States |
| FALCON Research Site | Houston | Texas | 77079 | United States |
| FALCON Research Site | San Antonio | Texas | 78229 | United States |
| FALCON Research Site | St. George | Utah | 84790 | United States |
| FALCON Research Site | Arlington | Virginia | 22206 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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