REMD-477 for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

Overseen ByRalph DeFronzo, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: The University of Texas Health Science Center at San Antonio

Trial Summary

What is the purpose of this trial?This trial tests a new drug that blocks glucagon, a hormone that raises blood sugar. It targets Type 2 Diabetes patients whose blood sugar is not well-controlled with current treatments. The drug aims to lower and stabilize blood sugar levels by preventing glucagon from working.

Eligibility Criteria

This trial is for Type 2 diabetes patients aged 18-70 with a BMI of 25-40 kg/m2 and HbA1c levels between 7.5-10%. Participants must be on stable diabetes medication, if any, for at least three months. Women must use contraception or be post-menopausal/surgically sterilized. Exclusions include major organ disease, significant heart/pulmonary issues, psychiatric disturbances, recent weight fluctuation, certain medications affecting insulin sensitivity, and contraindications to MRI.

Inclusion Criteria

I am a woman not breastfeeding, either post-menopausal, using birth control, or sterilized.

I am between 18-70 years old, have Type 2 diabetes, my BMI is between 25-40, and my HbA1c is between 7.5-10%.

I have been on the same diabetes medication dose for at least 3 months.

I have Type 2 Diabetes and am either not on medication or only take metformin, sulfonylureas, or SGLT-2 inhibitors.

I can communicate clearly and can legally consent to participate.

Exclusion Criteria

I haven't used certain diabetes medications for more than a week in the last year.

I do not have serious heart, blood vessel, or lung problems.

I or my family have a history of specific pancreatic or endocrine tumors.

I am unable to give my written consent voluntarily.

I do not have any major organ diseases as per my recent tests and exams.

I have not been treated with GLP-1 receptor agonists or insulin.

I do not have type 1 diabetes.

Participant Groups

The study tests REMD-477's effects on glucose tolerance and insulin sensitivity in liver, muscle, adipocytes (fat cells), beta cell function (insulin-producing cells), and inflammation in fat tissue among T2DM patients. It compares the drug against a placebo through subcutaneous injections to evaluate its potential benefits.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Glucagon Receptor Agonist (GRA) REMD-477 groupExperimental Treatment1 Intervention

Participants are assigned to a 12 week treatment of REMD-477

Group II: Placebo groupPlacebo Group1 Intervention

Participants are assigned to a 12 week course of placebo for REMD-477