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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-08

Study Completion Date

2024-08-13

Brief Summary

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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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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RGT001-075 Group

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

Group Type EXPERIMENTAL

RGT001-075

Intervention Type DRUG

Administered orally

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No