Obesity
Conditions
Brief summary
The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity
Interventions
DRUGRGT001-075
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Regor Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 and ≤ 75 years * Have a BMI ≥27 kg/m² and ≤ 45 kg/m² * Have had a stable body weight for the 3 months prior to randomization
Exclusion criteria
* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity * Have a prior or planned surgical treatment for obesity * Have or plan to have endoscopic and/or device-based therapy for obesity * Have any prior diagnosis of diabetes * Have an electrocardiogram (ECG) with abnormalities * Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years * Have a history of suicide attempt.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight in kilogram | 12 weeks | Change in body weight from baseline at Week 12 |
| Percentage of participants who achieve ≥5% and ≥10% body weight reduction | 12 weeks | Percentage of participants who achieve ≥5% and ≥10% body weight reduction at Week 12 |
| Change in Body mass index (BMI) in kg/m^2 | 12 weeks | Change in BMI from baseline at Week 12 |
| Change in waist circumference in centimetre | 12 weeks | Change in waist circumference from baseline at Week 12 . |
| Percent change in body weight | 12 weeks | Percent change in body weight from baseline at Week 12 |
| RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf) | 12 weeks | Analysis of AUC0-inf |
| RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax) | 12 weeks | Analysis of Cmax |
| RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax) | 12 weeks | Analysis of Tmax |
| RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2) | 12 weeks | Analysis of t1/2 |
| RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last) | 12 weeks | Analysis of AUC0-last |
Countries
United States
Outcome results
None listed