DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05297045

TerminatedPhase 2

A Study of Oral GLP1RA RGT001-075 in Adults With Type 2 Diabetes

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Oral RGT001-075 in Adult Patients With Uncontrollable Type 2 Diabetes Mellitus on Metformin Therapy

Asset

RGT001-075 / RGT-075

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

17

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 24.5-40•HbA1c 7-10.5%

Primary endpoint

•HbA1c, 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 IDNCT05297045
Org study IDRGT001-075_01-201

Timeline

Milestones

Study first posted2022-03-25actual
Study start2022-03-29actual
Primary completion2023-05-30actual
Study completion2023-05-30actual
Last update posted2023-11-18actual

Assets

Investigational agents

RGT001-075 / RGT-075

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes that has been treated with lifestyle modification and a stable dose of metformin ≥1000 mg/day (or maximum tolerated dose) for at least 3 months at the time of Screening
•Screening HbA1c 7.0-10.5%
•Male or female, age 18-75 years
•Screening BMI 24.5 - 40 kg/m2
•Either surgically sterile, abstinent, or willing to use a highly effective method of contraception for the entirety of the study, and not be pregnant or lactating if a woman of child-bearing potential

Exclusion criteria

•Has received within the preceding 3 months prior to Screening, another approved or investigational oral or injectable antidiabetic medication (including, but not limited to sulfonylureas, dipeptidyl peptidase-4 inhibitor [DPP-4i], sodium-glucose cotransport 2 inhibitors, alphaglucosidase inhibitors, meglitinides, thiazolidinediones) or insulin in addition to metformin therapy
•Has active GI disease including acute or chronic pancreatitis, severe gastroparesis or chronic malabsorption, inflammatory bowel disease, symptomatic gallbladder or biliary disease, known unstable liver disease, a diagnosis of fibrotic nonalcoholic steatohepatitis (NASH), Gilbert's syndrome, or obvious clinical signs or symptoms of liver disease including chronic active hepatitis B or C, or primary biliary cirrhosis, or elevated alanine aminotransferase (ALT) levels at Screening
•Has any history of myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary therapeutic intervention, transient ischemic attack, stroke, or decompensated congestive heart failure within previous 6 months prior to Screening
•Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
•Has active proliferative diabetic retinopathy or macular edema
•Has 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 cancer
•Has an active or untreated malignancy or has been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for <5 years prior to screening
•Has evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
•Has had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening
•Has been treated or plan to be treated with drugs or devices or surgery that promote weight loss within 3 months prior to screening

Endpoints (38)

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
19
Cardiometabolic biomarkers
8
Weight & body composition
5
Glycemic / diabetes
4
MASH / liver
1
Renal / kidney
1

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Change in mean body weight (absolute and %) from baseline to end of treatment in the modified intent-to-treat population

Time frame:up to 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index from baseline to end of treatment in the modified intent-to-treat population

Time frame:up to 16 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from baseline to end of treatment in the modified intent-to-treat population

Time frame:up to 16 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percentages of patients achieving ≥5% and/or ≥10% greater body weight loss

Time frame:up to 16 weeks

≥10% weight-loss responders

threshold achievement, improvement

components≥5% weight-loss responders, ≥10% weight-loss responders

Secondary/protocol endpoint

Vital signs - Body weight (kg) absolute and percent change from baseline

Time frame:up to 16 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population

Time frame:up to 16 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose from baseline to end of treatment in the modified intent-to-treat population

Time frame:up to 16 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentages of patients achieving HbA1c <6.0%, <6.5%, and/or <7.0%

Time frame:up to 16 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Safety clinical laboratories - fasting serum glucose absolute change from baseline

Time frame:up to 16 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

MASH / liver

1 endpoint
Secondary/protocol endpoint

Safety clinical laboratories - serum alanine aminotransferase absolute change from baseline

Time frame:up to 16 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Safety clinical laboratories - eGFR (calculated) absolute change from baseline

Time frame:up to 16 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

8 endpoints
Secondary/protocol endpoint

Change in mean blood lipids including triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from baseline to end of treatment in the modified intent-to-treat population

Time frame:up to 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Vital signs - Systolic blood pressure (mmHg) absolute change from baseline

Time frame:up to 16 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Vital signs - Diastolic blood pressure (mmHg) absolute change from baseline

Time frame:up to 16 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Vital signs - Heart rate (beats/minute) absolute change from baseline

Time frame:up to 16 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Safety clinical laboratories - fasting serum total cholesterol absolute change from baseline

Time frame:up to 16 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Safety clinical laboratories - fasting serum triglycerides absolute and percent change from baseline

Time frame:up to 16 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Safety clinical laboratories - fasting serum HDL-C absolute and percent change from baseline

Time frame:up to 16 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Safety clinical laboratories - fasting serum LDL-C absolute and percent change from baseline

Time frame:up to 16 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Safety / tolerability / PK

19 endpoints
Secondary/protocol endpoint

Incidence of treatment-emergent adverse events (TEAE)s, serious adverse events (SAE)s, deaths, and adverse events (AE)s leading to study discontinuation

Time frame:up to 16 weeks

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint), Discontinuation due to AE

Secondary/protocol endpoint

Safety clinical laboratories - complete blood count absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum sodium absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum potassium absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum total bilirubin absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum direct bilirubin absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum alkaline phosphatase absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum aspartate aminotransferase absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

LOINC 1920-8

Secondary/protocol endpoint

Safety clinical laboratories - serum blood urea nitrogen absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum creatinine absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum uric acid absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum calcium absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum lipase absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum amylase absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum albumin absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum total protein absolute change from baseline

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Safety clinical laboratories - serum calcitonin absolute change from screening

Time frame:up to 16 weeks

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

ECG interval change from baseline absolute and categorical outliers >450ms

Time frame:up to 16 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Proportion of patients who report AEs of Special Interest (AESI) including GI intolerability, hypoglycemia, drug hypersensitivity reactions, acute pancreatitis, thyroid C-cell hyperplasia and C-cell neoplasms, and cardiovascular (CV) events

Time frame:up to 16 weeks

threshold achievement, event

componentsNausea, Documented hypoglycemia, Immunogenicity (ADA), Pancreatitis, Thyroid event, Expanded / custom MACE composite

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.