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CompletedPhase EARLY_1

Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM

Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in Type 2 Diabetes Mellitus (T2DM)

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

4

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 25-40HbA1c 7.5-10%

Primary endpoints

HbA1c, changeFasting glucose, changePostprandial glucose

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 IDNCT05093517
Org study IDHSC20210463H

Timeline

Milestones

Study first posted2021-10-26actual
Study start2021-11-10actual
Primary completion2022-03-16actual
Study completion2022-03-16actual
Last update posted2024-08-09actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Type 2 diabetic subjects, males/females;

2. age = 18-70 years

3. BMI = 25-40 kg/m2;

4. HbA1c = 7.5-10.0%;

5. Type 2 Diabetics who are drug naïve or treated with metformin, sulfonylureas, SGLT-2 inhibitors or any combination thereof.

6. Subjects must be on a stable dose of antidiabetic medications for at least 3 months prior to study.

7. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.

8. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period

Exclusion criteria

1. Subjects with a personal or family history of pancreatic neuroendocrine tumors or multiple endocrine neoplasia, due to the potential increased of pancreatic alpha cell carcinogenicity associated with glucagon receptor antagonists.

2. Subjects with a contraindication to MRI including artificial heart valves or pacemakers

3. Patients with a known sensitivity to humanized antibodies

4. Subjects treated with GLP-1 RAs or insulin are excluded.

5. Subjects treated with a non-antidiabetic medication that may impact insulin sensitivity, such as systemic steroids, or lipase inhibitors (orlistat, Alli or Xenical)

6. Hematocrit < 34 vol%

7. Serum creatinine > 1.8 mg/dl

8. AST (SGOT) > 2 times upper limit of normal

9. ALT (SGPT) > 2 times upper limit of normal

10. Any major organ system disease as identified by medical history, physical exam, and screening blood tests, EKG

11. Subjects who cannot give written, voluntary consent

12. Subjects with a major psychiatric disturbance

13. Only subjects whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.

14. Patients must not have type 1 diabetes

15. Patients must not have a fasting plasma glucose of greater than 270 mg/dl or HbA1c > 10.0%

16. Patients must not have received a thiazolidinedione, GLP-1 agonist, or insulin for more than one week during the year prior to randomization

17. Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.

Endpoints (7)

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

Glycemic / diabetes
6
Cardiometabolic biomarkers
1

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Glycated Hemoglobin (HbA1c)

Time frame:Baseline to 13 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Fasting Plasma glucose (FPG)

Time frame:Baseline to 13 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Plasma glucose (PG)

Time frame:Baseline to 13 weeks

Postprandial glucose

change from baseline, improvement

Primary/protocol endpoint

Hepatic insulin sensitivity

Time frame:Baseline to 13 weeks

change from baseline, improvement

Primary/protocol endpoint

Whole body glucose disposal

Time frame:Baseline to 13 weeks

change from baseline, improvement

Primary/protocol endpoint

Muscle Insulin sensitivity

Time frame:Baseline to 13 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Primary/protocol endpoint

Plasma Free Fatty Acids (FFA)

Time frame:Baseline to 13 weeks

Free fatty acids, change

change from baseline, improvement

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.