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The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RGT001-075 Group | Experimental | Patients will receive once daily dose of study drug for a total of 12 weeks |
|
| Placebo Group | Placebo Comparator | Patients will receive once daily dose of matching placebo for a total of 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGT001-075 | Drug | Administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight | Percent change in body weight from baseline at Week 12 | 12 weeks |
| Change in body weight in kilogram | Change in body weight from baseline at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research | Los Angeles | California | 90057 | United States | ||
| Velocity Clinical Research |
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| Drug |
Administered orally |
|
| 12 weeks |
| Percentage of participants who achieve ≥5% and ≥10% body weight reduction | Percentage of participants who achieve ≥5% and ≥10% body weight reduction at Week 12 | 12 weeks |
| Change in Body mass index (BMI) in kg/m^2 | Change in BMI from baseline at Week 12 | 12 weeks |
| Change in waist circumference in centimetre | Change in waist circumference from baseline at Week 12 . | 12 weeks |
| RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last) | Analysis of AUC0-last | 12 weeks |
| RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf) | Analysis of AUC0-inf | 12 weeks |
| RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax) | Analysis of Cmax | 12 weeks |
| RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax) | Analysis of Tmax | 12 weeks |
| RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2) | Analysis of t1/2 | 12 weeks |
| Valparaiso |
| Indiana |
| 46383 |
| United States |
| Velocity Clinical Research | Omaha | Nebraska | 68134 | United States |
| Velocity Clinical Research | Vestal | New York | 13850 | United States |
| Velocity Clinical Research | Durham | North Carolina | 27701 | United States |
| Velocity Clinical Research | Cleveland | Ohio | 44122 | United States |
| Velocity Clinical Research | Medford | Oregon | 97504 | United States |
| Velocity Clinical Research | East Greenwich | Rhode Island | 02818 | United States |
| Velocity Clinical Research | Dallas | Texas | 75230 | United States |
| Velocity Clinical Research | West Jordan | Utah | 84088 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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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