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HomeTrials › NCT04779645

Type 2 diabetes · Phase 2 · Active, not recruiting

Effects of GRA in Patients With Type 1

NCT04779645 · Sponsor: University of California, San Diego

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying REMD-477, Placebo for type 1 diabetes.

Who can joinAll sexes, 18 Years – 65 Years
Healthy volunteersNo — diagnosis required
What you'd takeREMD-477, Placebo
Study length~3 years overall
Planned participants30
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

This study will examine the effects a Glucagon Receptor Antagonist (GRA), has on Insulin Sensitivity, Cardiovascular risks (CVD), and Ketone body formation in participants with Type 1 diabetes. The participants will complete blood tests, tests to measure energy expenditure, CVD risks, and insulin resistance. These tests will be performed prior to start of treatment and again after 12-weeks of treatment with the GRA (called REMD-477).

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: 1. Men and women between the ages of 18 and 65 years old, inclusive, at the time of screening; 2. Females of non-child bearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of child bearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product; 3. Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 6 months after the end of the treatment period; 4. Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria for \> 5 years; 5. Treatment with a stable insulin regimen for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump; 6. Currently using a Continuous Glucose Monitoring (CGM) system; 7. HbA1c ≤ 8.5 % at screening; 8. A minimum weight of 50kg; 9. eGFR ≥ 60 mL/min/1.73m² 10. Able to provide written informed consent approved by an Institutional Review Board (IRB). Exclusion Criteria: 1. 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; 2. History of pancreatitis, medullary thyroid carcinoma and/or liver disease; 3. Clinically significant diagnosis of anemia; 4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight less than 50kg; 5. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion; 6. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; 7. Women who are pregnant or lactating/breastfeeding; 8. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits; 9. 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.

Study sites by state

California

  • UC San Diego Altman Clinical & Translational Research Institute — La Jolla

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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