30 Participants Needed

GRA (REMD-477) for Type 1 Diabetes

TM
Overseen ByTodd May
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Diego
Must be taking: Insulin
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests a drug called REMD-477, which blocks a hormone that raises blood sugar, in people with Type 1 diabetes. The goal is to see if it helps with insulin sensitivity and heart health. Participants will receive the drug for several months while continuing their usual insulin therapy. REMD-477 is being tested for its effectiveness in type 1 diabetes.

Eligibility Criteria

This trial is for men and women aged 18-65 with Type 1 diabetes for over 5 years, using a CGM system, HbA1c ≤ 8.5%, and on a stable insulin regimen via pump. Participants must use contraception and have an eGFR ≥60 mL/min/1.73m². Excluded are those with pancreatitis, liver disease, other significant health risks or recent non-insulin diabetes meds usage.

Inclusion Criteria

Your kidney function is normal.
Your HbA1c level is less than or equal to 8.5% at the time of screening.
I weigh at least 50kg.
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Exclusion Criteria

Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent
History or evidence of clinically-significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
I have used diabetes medication other than insulin in the last month.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Participants complete cardiovascular tests, hyperinsulinemic/euglycemic clamp, and insulin withdrawal challenge

1 week
3 visits (in-person)

Treatment

Participants receive weekly injections of REMD-477 or placebo and undergo various assessments

12 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

Treatment Details

Interventions

  • REMD-477
Trial Overview The study tests the effects of REMD-477 (a Glucagon Receptor Antagonist) on insulin sensitivity, cardiovascular risk factors, and ketone body formation in Type 1 diabetics compared to placebo over a period of 12 weeks with prior and post-treatment evaluations including blood tests.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GRA (REMD-477) GroupExperimental Treatment1 Intervention
Once weekly, subcutaneous injection of 70mg REMD-477 (in 1 mL solution) for up to 12 weeks.
Group II: Placebo GroupPlacebo Group1 Intervention
Once weekly, subcutaneous injection of 1mL saline solution for up to 12 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

REMD Biotherapeutics, Inc.

Industry Sponsor

Trials
7
Recruited
320+
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