Clinical trial NCT06277934: A Study of RGT001-075 in Adult Patients With Obesity
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Regor Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 14 weeks
Secondary outcomes:
measure: Percent change in body weight
timeFrame: 12 weeks
measure: Change in body weight in kilogram
timeFrame: 12 weeks
measure: Percentage of participants who achieve ≥5% and ≥10% body weight reduction
timeFrame: 12 weeks
measure: Change in Body mass index (BMI) in kg/m^2
timeFrame: 12 weeks
measure: Change in waist circumference in centimetre
timeFrame: 12 weeks
measure: RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)
timeFrame: 12 weeks
measure: RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)
timeFrame: 12 weeks
measure: RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)
timeFrame: 12 weeks
measure: RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)
timeFrame: 12 weeks
measure: RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Velocity Clinical Research
state: California
city: Valparaiso
country: United States
facility: Velocity Clinical Research
state: Indiana
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Vestal
country: United States
facility: Velocity Clinical Research
state: New York
city: Durham
country: United States
facility: Velocity Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research
state: Oregon
city: East Greenwich
country: United States
facility: Velocity Clinical Research
state: Rhode Island
city: Dallas
country: United States
facility: Velocity Clinical Research
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research
state: Utah
Study officials:
References: