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This randomized, double-blind, placebo-controlled phase IIa study is designed to evaluate the efficacy, safety, and tolerability of ASC30 Tablets and ASC30 Tablets A1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily. |
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| Cohort 2 | Experimental | Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily. |
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| Cohort 3 | Experimental | Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily. |
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| Cohort 4 | Experimental | Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily. |
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| Cohort 5 | Experimental | Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily. |
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| Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC30 tablets or ASC30 tablets A1 or placebo | Drug | Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from Baseline up to Week 13 | Baseline and Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight (absolute) from Baseline up to Week 13 | Baseline and Week 13 | |
| Change in waist circumference from Baseline up to Week 13 | Baseline and Week 13 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascletis Clinical Site | Rogers | Arkansas | 72758 | United States | ||
| Ascletis Clinical Site |
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| Experimental |
Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily. |
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| Cohort 7 | Experimental | Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily. |
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| Change in body mass index from Baseline to Week 13 |
| Baseline and Week 13 |
| Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Baseline and Week 13 |
| Fort Myers |
| Florida |
| 33912 |
| United States |
| Ascletis Clinical Site | Miami | Florida | 33172 | United States |
| Ascletis Clinical Site | Columbus | Ohio | 43212 | United States |
| Ascletis Clinical Site | Bellaire | Texas | 77401 | United States |
| Ascletis Clinical Site | San Antonio | Texas | 78240 | United States |