Obesity or Overweight
Conditions
Keywords
GLP-1 receptor agonist (GLP-1 RA), Obesity
Brief summary
This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.
Interventions
DRUGRGT001-075
RGT001-075 is a small molecule GLP-1 agonist
DRUGPlacebo Comparator
Placebo comparator
Sponsors
Regor Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, age 18-75 years (inclusive) at the time of signing informed consent. 2. Hemoglobin A1c (HbA1c) \<6.5% at screening. 3. BMI ≥30 kg/m². 4. BMI ≥27 kg/m² and \<30 kg/m² with at least 1 weight-related comorbidity: * hypertension * dyslipidemia * cardiovascular (CV) disease * obstructive sleep apnea 5. Have a stable body weight (\< 5% change) for the 3 months prior to randomization.
Exclusion criteria
(Obesity Related): 1. Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome). 2. Have a prior or planned surgical treatment for obesity. 3. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months before screening such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner. 4. Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in body weight at Week 36 | Baseline and 36 weeks | Least Squares (LS) mean using mixed model repeated measures (MMRM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in body weight at Week 26 | Baseline and 26 weeks | Least Squares (LS) mean using mixed model repeated measures (MMRM) |
| Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall | Baseline through week 36 | To evaluate the safety and tolerability of RGT001-075 for weight loss in adults who are obese, or overweight with at least one weight-related comorbidity |
| Ambulatory Blood Pressure Monitoring (ABPM) | Baseline, 26 weeks | The ABPM device will be attached to the nondominant arm, and participants will be instructed to wear the monitor for a 24- to 27-hour period. |
| AUC0-last | week 15 | Area under the serum concentration curve from time-zero to the last quantifiable concentration of RGT001-075 |
| AUC0-inf | week 15 | Area under curve from time zero to time infinite |
| Cmax | week15 | Maximum concentration of RT001-075 |
| Tmax | week 15 | Time to achieve maximum concentration of RT001-075 |
| t1/2 | week 15 | Terminal half-life of RGT001-075 |
Countries
United States
Outcome results
None listed