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This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.
This study is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study in adult participants with obesity. Approximately 70 participants will be randomized in a 1:1 ratio to GLY-200 (2.0 g, twice daily) or placebo (twice daily). There will be a ≤ 28-day screening period. Dosing will occur for 16 weeks. Clinic visits will occur at Screening, Week 0 (Day 1), and Weeks 1, 2, 4, 6, 8, 12, 16, and 17 [End of Study (EOS)] or Early Termination (ET). Phone visits will occur at Week 3, 10, and 14.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLY-200 | Experimental | Participants will receive 2.0 g GLY-200 orally twice daily for 16 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo (identical in appearance to GLY-200) orally twice daily for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLY-200 | Drug | 2.0 g GLY-200 (4 x 0.5 g capsules) orally twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in weight | Baseline and Week 16 | |
| Proportion of participants who achieve ≥ 5% body weight reduction | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change and percent change from baseline in weight | Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16 | |
| Change from baseline in waist circumference | Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Fineman, PhD | Glyscend, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa Bay Medical Research, Inc. | Clearwater | Florida | 33761 | United States | ||
| Sensible Healthcare, LLC |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Drug |
4 placebo capsules orally twice daily |
|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) considered by the Investigator to be related to study drug administration | Over the 16-week treatment period |
| Ocoee |
| Florida |
| 34761 |
| United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Mercury Street Medical | Butte | Montana | 59701 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |