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The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity.
The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Part C) MET097 | Experimental | Once-weekly subcutaneous injection of MET097 for 13 weeks |
|
| (Part C) Placebo | Placebo Comparator | Once-weekly subcutaneous injection of Placebo for 13 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (Part C) MET097 | Biological | Participants will receive 13 once-weekly subcutaneous injections of MET097 as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| (Part C) Percent change from baseline in body weight at Week 12 (Day 85). | Day 1 (Week 0) to Day 85 (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| (Part C) To characterize the maximum observed concentration (Cmax). | Day 1 (Week 0) to Day 160 (Week 31) | |
| (Part C) To characterize the time of maximum observed concentration (Tmax). | Day 1 (Week 0) to Day 160 (Week 31) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site MET097 23-101-002 | Anaheim | California | 92801 | United States | ||
| Research Site MET097 23-101-003 |
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Part A (72 participants), Part B (70 participants), Part C (120 participants)
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|
| (Part C) Placebo | Biological | Participants will receive 13 once-weekly subcutaneous injections of matching placebo |
|
| (Part C) To characterize the area under the concentration versus time curve (AUC). | Day 1 (Week 0) to Day 160 (Week 31) |
| (Part C) To characterize the elimination half-life (t1/2). | Day 1 (Week 0) to Day 160 (Week 31) |
| (Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12. | Day 1 (Week 0) to Day 85 (Week 12) |
| (Part C) Occurrence of TEAEs following the 13th dose. | Day 85 (Week 12) to Day 160 (Week 31) |
| Cypress |
| California |
| 90630 |
| United States |
| Research Site MET097 23-101-001 | Overland Park | Kansas | 66212 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 12, 2026 | Mar 31, 2026 | 2 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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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