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COMO-1

CompletedPhase 2

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 of Once-Daily RGT001-075 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities (COMO-1)

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 ≥30HbA1c ≤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

NCT IDNCT06867718
Org study IDRGT001-075-205

Timeline

Milestones

Study start2025-01-24actual
Study first posted2025-03-10actual
Primary completion2025-11-06actual
Study completion2025-11-06actual
Last update posted2026-05-28actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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:

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

(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

Safety / tolerability / PK
6
Weight & body composition
2
Cardiometabolic biomarkers
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Percent change from baseline in body weight at Week 36

Time frame:Baseline and 36 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Ambulatory Blood Pressure Monitoring (ABPM)

Time frame:Baseline, 26 weeks

descriptive, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Incidence 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)

Secondary/protocol endpoint

AUC0-last

Time frame:week 15

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC0-inf

Time frame:week 15

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax

Time frame:week15

Cmax

concentration, descriptive

Secondary/protocol endpoint

Tmax

Time frame:week 15

Tmax

descriptive

Secondary/protocol endpoint

t1/2

Time frame:week 15

Half-life

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.