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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 25-40•HbA1c 7.5-10%
Primary endpoints
•HbA1c, change•Fasting glucose, change•Postprandial 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsGlycated Hemoglobin (HbA1c)
Time frame:Baseline to 13 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Fasting Plasma glucose (FPG)
Time frame:Baseline to 13 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Plasma glucose (PG)
Time frame:Baseline to 13 weeks
Postprandial glucose
change from baseline, improvement
Hepatic insulin sensitivity
Time frame:Baseline to 13 weeks
change from baseline, improvement
Whole body glucose disposal
Time frame:Baseline to 13 weeks
change from baseline, improvement
Muscle Insulin sensitivity
Time frame:Baseline to 13 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointPlasma Free Fatty Acids (FFA)
Time frame:Baseline to 13 weeks
Free fatty acids, change
change from baseline, improvement
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.