A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities

Regor Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: RGT001-075; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06277934

RGT001-075-203

Details and patient eligibility

About

The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity

Enrollment: 73 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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73 participants in 2 patient groups, including a placebo group

RGT001-075 Group

Experimental group

Description:

Patients will receive once daily dose of study drug for a total of 12 weeks

Treatment:

Drug: RGT001-075

Placebo Group

Placebo Comparator group

Description:

Patients will receive once daily dose of matching placebo for a total of 12 weeks

Treatment:

Drug: Placebo