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COMO-1
CompletedPhase 2Study 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 of Once-Daily RGT001-075 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities (COMO-1)
Lead sponsor
Asset
RGT001-075 / RGT-075
Oral · GLP-1 agonist
Listed sites
35
Recruiting sites
—
Enrollment
267
actual
Study population
Obesity / overweight
Key I/E criteria
•BMI ≥30•HbA1c ≤6.5%
Primary endpoint
•Body weight, % change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Male or female, age 18-75 years (inclusive) at the time of signing informed consent.
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:
5. Have a stable body weight (< 5% change) for the 3 months prior to randomization.
Exclusion criteria
(Obesity Related):
1. 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).
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.
Exclusion Criteria (Medical Conditions)
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.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsPercent change from baseline in body weight at Week 36
Time frame:Baseline and 36 weeks
Body weight, % change
percent change from baseline, improvement
Percent change from baseline in body weight at Week 26
Time frame:Baseline and 26 weeks
Body weight, % change
percent change from baseline, improvement
Cardiometabolic biomarkers
1 endpointAmbulatory Blood Pressure Monitoring (ABPM)
Time frame:Baseline, 26 weeks
descriptive, improvement
Safety / tolerability / PK
6 endpointsIncidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall
Time frame:Baseline through week 36
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
AUC0-last
Time frame:week 15
AUC₀–∞
concentration, descriptive
AUC0-inf
Time frame:week 15
AUC₀–∞
concentration, descriptive
Cmax
Time frame:week15
Cmax
concentration, descriptive
Tmax
Time frame:week 15
Tmax
descriptive
t1/2
Time frame:week 15
Half-life
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.