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

Regor Pharmaceuticals Inc.73 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity

Interventions

RGT001-075DRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (10)

Velocity Clinical Research

Los Angeles, California, United States

Velocity Clinical Research

Valparaiso, Indiana, United States

Velocity Clinical Research

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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

Time frame: 14 weeks

Secondary Outcomes

Percent change in body weight

Percent change in body weight from baseline at Week 12

Time frame: 12 weeks

Change in body weight in kilogram

Change in body weight from baseline at Week 12

Time frame: 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

Time frame: 12 weeks

Change in Body mass index (BMI) in kg/m^2

Change in BMI from baseline at Week 12

Time frame: 12 weeks

Change in waist circumference in centimetre

Change in waist circumference from baseline at Week 12 .

Time frame: 12 weeks

RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)

Analysis of AUC0-last

Time frame: 12 weeks

RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)

Analysis of AUC0-inf

Data from ClinicalTrials.gov

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