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Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg twice daily [BID]) or placebo for 5 days beginning on Day 1. On Day 2, all participants will receive a single subcutaneous injection of a Glucagon-like Peptide-1 (GLP-1) agonist (semaglutide). Participants will remain at the clinical research unit for the duration of the treatment period.
The goal of this clinical trial is to evaluate the safety and efficacy of NG101 compared to placebo, when also administered along with a GLP-1 agonist, in the management of gastrointestinal side effects commonly associated with GLP-1 agonists for overweight or obesity. Adverse event information will be collected. Gastrointestinal (GI)-specific questionnaires will be used to capture additional details if GI-related adverse events are reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NG101 20 mg BID | Experimental | NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide |
|
| Placebo | Placebo Comparator | Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NG101 | Drug | NG101 20 mg BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of GI-related adverse events | Number of days with TEAEs of GI-related adverse events following GLP-1 agonist injection | 96 hours following GLP-1 agonist injection |
| Severity of GI-related adverse events | Moderate and/or severe TEAES of GI-related adverse events following GLP-1 agonist injection | 96 hours following GLP-1 agonist injection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of TEAEs of GI-related adverse events | Number of TEAEs of GI-related adverse events following GLP-1 agonist injection | 96 hours following GLP-1 agonist injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | Placebo BID |
|
| Semaglutide Injectable Product | Drug | Semaglutide 0.5 or 1 mg |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |