GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight With Weight-Related Comorbidities

Lead sponsor

Regor Pharmaceuticals Inc.

Asset

RGT001-075 / RGT-075

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE)

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 IDNCT06277934

Org study IDRGT001-075-203

Timeline

Milestones

Study first posted2024-02-26actual

Study start2024-03-08actual

Primary completion2024-08-13actual

Study completion2024-08-13actual

Last update posted2025-08-07actual

Assets

Investigational agents

RGT001-075 / RGT-075

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (11)

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

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Percent change in body weight

Time frame:12 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight in kilogram

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage of participants who achieve ≥5% and ≥10% body weight reduction

Time frame:12 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body mass index (BMI) in kg/m^2

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference in centimetre

Time frame:12 weeks

change from baseline, improvement

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

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

Time frame:14 weeks

change from baseline, event

Secondary/protocol endpoint

RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)

Time frame:12 weeks

concentration, descriptive

Secondary/protocol endpoint

RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)

Time frame:12 weeks

concentration, descriptive

Secondary/protocol endpoint

RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)

Time frame:12 weeks

threshold achievement, event

Secondary/protocol endpoint

RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)

Time frame:12 weeks

concentration, 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.