Obesity or OverweightPhase 2COMO-1NCT06867718
Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions
A Phase 2 study testing RGT001-075 in people with Obesity or Overweight, run by Regor Pharmaceuticals Inc. at 35 sites in United States.
Trial summary
This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity or Overweight
- What is being tested?
- RGT001-075
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 35 sitesUnited States
- Study dates
- 24 Jan 2025to 6 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18-75 years (inclusive) at the time of signing informed consent.
- Hemoglobin A1c (HbA1c) <6.5% at screening.
- BMI ≥30 kg/m².
- BMI ≥27 kg/m² and <30 kg/m² with at least 1 weight-related comorbidity:
- hypertension
- dyslipidemia
Show all 9Show fewer
- cardiovascular (CV) disease
- obstructive sleep apnea
- Have a stable body weight (< 5% change) for the 3 months prior to randomization.
Who cannot join
- Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
- Have a prior or planned surgical treatment for obesity.
- 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.
- Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.
- Diabetes.
- Have a history of acute or chronic pancreatitis.
Show all 13Show fewer
- Have current symptomatic gallbladder disease or biliary disease.
- Have known liver disease other than MASLD.
- 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).
- Have a serum calcitonin ≥20 pg/mL.
- Have an eGFR <30 mL/min/1.73 m², as determined by the central laboratory at screening.
- Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
- 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.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Velocity Clinical Research
Baton Rouge, Louisiana, 70809
Javara-Tryon Medical Partners, PLLC
Charlotte, North Carolina, 28287
Velocity Clinical Research
Cincinnati, Ohio, 45246
Velocity Clinical Research
Cleveland, Ohio, 44122
Synexus Clinical Research
Creve Coeur, Missouri, 63141
Velocity Clinical Research
Dallas, Texas, 75230
Synexus Clinical Research
Dallas, Texas, 75234
Angels Clinical Research
Doral, Florida, 33122
Velocity Clinical Research
Durham, North Carolina, 27701
Velocity Clinical Research
East Greenwich, Rhode Island, 02818
Synexus Clinical Research
Evansville, Indiana, 47714
Velocity Clinical Research
Huntington Park, California, 90255
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509
Mankato Clinic-East Main Street-Javara
Mankato, Minnesota, 56001
Optimal Research
Melbourne, Florida, 32934
Angels Clinical Research
Miami, Florida, 33126
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
Velocity Clinical Research
Omaha, Nebraska, 68134
Synexus Clinical Research
Phoenix, Arizona, 85020
Synexus Clinical Research
Richfield, Minnesota, 55423
Velocity Clinical Research
Rockville, Maryland, 20854
Synexus Clinical Research
Salt Lake City, Utah, 84106
Synexus Clinical Research
San Antonio, Texas, 78229
Javara-Privia Medical Group, Georgia LLC
Savannah, Georgia, 31406
Velocity Clinical Research
Seattle, Washington, 98105
Premier Health Research-Sparta-Objective Health
Sparta, New Jersey, 07871
Synexus Clinical Research
The Villages, Florida, 32162
Javara-Privia Medical Group Gulf Coast PLLC
The Woodlands, Texas, 77384
Javara-Privia Medical Group, Georgia, LLC
Thomasville, Georgia, 31792
Velocity Clinical Research
Valparaiso, Indiana, 46383
Velocity Clinical Research
Vestal, New York, 13850
Velocity Clinical Research
Waco, Texas, 76710
Velocity Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A Phase 2 Study of Once-Daily RGT001-075 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities (COMO-1)
This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.
- Conditions
- Obesity or Overweight
- Being tested
- RGT001-075, Placebo Comparator
- Keywords
- GLP-1 receptor agonist (GLP-1 RA), Obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGT001-075Drug
RGT001-075 is a small molecule GLP-1 agonist
Placebo ComparatorDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| RGT1 | Experimental | Study Drug: RGT001-075 (Dose 1) Receives: Drug: RGT001-075 |
| RGT2 | Experimental | Study Drug: RGT001-075 (Dose 2) Receives: Drug: RGT001-075 |
| RGT3 | Experimental | Study Drug: RGT001-075 (Dose 3) Receives: Drug: RGT001-075 |
| RGT4 | Experimental | Study Drug: RGT001-075 (Dose 4) Receives: Drug: RGT001-075 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in body weight at Week 36
Least Squares (LS) mean using mixed model repeated measures (MMRM)
Measured: Baseline and 36 weeks
Secondary outcomes (8)
Percent change from baseline in body weight at Week 26
Least Squares (LS) mean using mixed model repeated measures (MMRM)
Measured: Baseline and 26 weeks
Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall
To evaluate the safety and tolerability of RGT001-075 for weight loss in adults who are obese, or overweight with at least one weight-related comorbidity
Measured: Baseline through week 36
Ambulatory Blood Pressure Monitoring (ABPM)
The ABPM device will be attached to the nondominant arm, and participants will be instructed to wear the monitor for a 24- to 27-hour period.
Measured: Baseline, 26 weeks
AUC0-last
Area under the serum concentration curve from time-zero to the last quantifiable concentration of RGT001-075
Measured: week 15
AUC0-inf
Area under curve from time zero to time infinite
Measured: week 15
Cmax
Maximum concentration of RT001-075
Measured: week15
Tmax
Time to achieve maximum concentration of RT001-075
Measured: week 15
t1/2
Terminal half-life of RGT001-075
Measured: week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start24 Jan 2025
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity or OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regor Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867718
- Sponsor's protocol ID
- RGT001-075-205
- Acronym
- COMO-1
- Status last verified
- May 2026
- First submitted
- 14 Feb 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Sponsor recognizes that sharing anonymized data and other information from clinical trials can enhance biomedical research. The Sponsor is following ongoing discussions among industry, academia, and other stakeholders regarding data sharing. Industry and academic partners hold various positions on the amount, types, and forms of data that will be useful l to the research community, the public, and the process for sharing. As a small, young company, the Sponsor awaits further guidance and input from industry participants on best practices before issuing a comprehensive data sharing plan. For now, Sponsor defers a description of what data will be shared and the process for doing so.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Once-Daily RGT001-075 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities (COMO-1)
- ClinicalTrials.gov ID
- NCT06867718
- Acronym / sponsor ID
- COMO-1 / RGT001-075-205
- Conditions
- Obesity or Overweight
- Keywords
- GLP-1 receptor agonist (GLP-1 RA), Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Regor Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RGT1 | Experimental | Drug: RGT001-075Study Drug: RGT001-075 (Dose 1) |
| RGT2 | Experimental | Drug: RGT001-075Study Drug: RGT001-075 (Dose 2) |
| RGT3 | Experimental | Drug: RGT001-075Study Drug: RGT001-075 (Dose 3) |
| RGT4 | Experimental | Drug: RGT001-075Study Drug: RGT001-075 (Dose 4) |
| Placebo | Placebo comparator | Drug: Placebo ComparatorPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age 18-75 years (inclusive) at the time of signing informed consent.
- Hemoglobin A1c (HbA1c) <6.5% at screening.
- BMI ≥30 kg/m².
- BMI ≥27 kg/m² and <30 kg/m² with at least 1 weight-related comorbidity:
- Have a stable body weight (< 5% change) for the 3 months prior to randomization.
Key exclusion criteria (13 listed)
- Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
- Have a prior or planned surgical treatment for obesity.
- 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.
- Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.
- Diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGT001-075RGT001-075 is a small molecule GLP-1 agonist | Drug | RGT1, RGT2, RGT3, RGT4 |
| Placebo ComparatorPlacebo comparator | Drug | Placebo |
Primary outcome
Percent change from baseline in body weight at Week 36
Time frame: Baseline and 36 weeks
Least Squares (LS) mean using mixed model repeated measures (MMRM)
8 secondary outcomes
Percent change from baseline in body weight at Week 26
Time frame: Baseline and 26 weeks
Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall
Time frame: Baseline through week 36
Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: Baseline, 26 weeks
AUC0-last
Time frame: week 15
AUC0-inf
Time frame: week 15
Cmax
Time frame: week15
Tmax
Time frame: week 15
t1/2
Time frame: week 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided. The Sponsor recognizes that sharing anonymized data and other information from clinical trials can enhance biomedical research. The Sponsor is following ongoing discussions among industry, academia, and other stakeholders regarding data sharing. Industry and academic partners hold various positions on the amount, types, and forms of data that will be useful l to the research community, the public, and the process for sharing. As a small, young company, the Sponsor awaits further guidance and input from industry participants on best practices before issuing a comprehensive data sharing plan. For now, Sponsor defers a description of what data will be shared and the process for doing so.
Related trials for Obesity or Overweight
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RGT001-075 in people with Obesity or Overweight, run by Regor Pharmaceuticals Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in body weight at Week 36 (time frame: Baseline and 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.