Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions
NCT ID: NCT06867718
Last Updated: 2025-04-02
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
236 participants
INTERVENTIONAL
2025-01-24
2025-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RGT1
Study Drug: RGT001-075 (Dose 1)
RGT001-075
RGT001-075 is a small molecule GLP-1 agonist
RGT2
Study Drug: RGT001-075 (Dose 2)
RGT001-075
RGT001-075 is a small molecule GLP-1 agonist
RGT3
Study Drug: RGT001-075 (Dose 3)
RGT001-075
RGT001-075 is a small molecule GLP-1 agonist
RGT4
Study Drug: RGT001-075 (Dose 4)
RGT001-075
RGT001-075 is a small molecule GLP-1 agonist
Placebo
Placebo
Placebo Comparator
Placebo comparator
Interventions
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RGT001-075
RGT001-075 is a small molecule GLP-1 agonist
Placebo Comparator
Placebo comparator
Eligibility Criteria
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Inclusion Criteria
2. Hemoglobin A1c (HbA1c) \<6.5% at screening.
3. BMI ≥30 kg/m².
4. BMI ≥27 kg/m² and \<30 kg/m² with at least 1 weight-related comorbidity:
* hypertension
* dyslipidemia
* cardiovascular (CV) disease
* obstructive sleep apnea
5. Have a stable body weight (\< 5% change) for the 3 months prior to randomization.
Exclusion Criteria
2. Have a prior or planned surgical treatment for obesity.
3. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months before screening such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner.
4. Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.
1. Diabetes.
2. Have a history of acute or chronic pancreatitis.
3. Have current symptomatic gallbladder disease or biliary disease.
4. Have known liver disease other than MASLD.
5. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).
6. Have a serum calcitonin ≥20 pg/mL.
7. Have an eGFR \<30 mL/min/1.73 m², as determined by the central laboratory at screening.
8. Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
9. Have had any exposure to GLP-1 analogs, or other related compounds within the prior 3 months or any prior history of clinically significant side effects from GLP-1 receptor agonist (GLP-1 RA) or other related compounds containing GLP-1.
18 Years
75 Years
ALL
No
Sponsors
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Regor Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
Synexus Clinical Research
Phoenix, Arizona, United States
Velocity Clinical Research
Huntington Park, California, United States
Angels Clinical Research
Doral, Florida, United States
Optimal Research
Melbourne, Florida, United States
Angels Clinical Research
Miami, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Synexus Clinical Research
The Villages, Florida, United States
Javara-Privia Medical Group, Georgia LLC
Savannah, Georgia, United States
Javara-Privia Medical Group, Georgia, LLC
Thomasville, Georgia, United States
Synexus Clinical Research
Evansville, Indiana, United States
Velocity Clinical Research
Valparaiso, Indiana, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, United States
Velocity Clinical Research
Baton Rouge, Louisiana, United States
Velocity Clinical Research
Rockville, Maryland, United States
Mankato Clinic-East Main Street-Javara
Mankato, Minnesota, United States
Synexus Clinical Research
Richfield, Minnesota, United States
Synexus Clinical Research
Creve Coeur, Missouri, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Premier Health Research-Sparta-Objective Health
Sparta, New Jersey, United States
Velocity Clinical Research
Vestal, New York, United States
Javara-Tryon Medical Partners, PLLC
Charlotte, North Carolina, United States
Velocity Clinical Research
Durham, North Carolina, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Velocity Clinical Research
Cleveland, Ohio, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, United States
Velocity Clinical Research
East Greenwich, Rhode Island, United States
Velocity Clinical Research
Dallas, Texas, United States
Synexus Clinical Research
Dallas, Texas, United States
Synexus Clinical Research
San Antonio, Texas, United States
Javara-Privia Medical Group Gulf Coast PLLC
The Woodlands, Texas, United States
Velocity Clinical Research
Waco, Texas, United States
Synexus Clinical Research
Salt Lake City, Utah, United States
Velocity Clinical Research
West Jordan, Utah, United States
Velocity Clinical Research
Seattle, Washington, United States
Countries
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Other Identifiers
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RGT001-075-205
Identifier Type: -
Identifier Source: org_study_id
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