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Glucagon Receptor Antagonist

GRA (REMD-477) for Type 1 Diabetes

Phase 2
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women between the ages of 18 and 65 years old, inclusive, at the time of screening
A minimum weight of 50kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights

Study Summary

This trial will look at the effects of a new diabetes medication on blood sugar levels, heart health, and ketone production in people with Type 1 diabetes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include changes in blood sugar levels that could affect diabetes management, possible impacts on liver function due to the drug's mechanism of action as it targets glucagon receptors which play a role in glucose metabolism.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I weigh at least 50kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Beta-hydroxybutyrate (BHB) Level
Change in Cardiovascular Disease (CVD) Risk Markers.
Change in Free Fatty Acid (FFA) Level
+5 more

Side effects data

From 2021 Phase 2 trial • 154 Patients • NCT03117998
16%
Upper respiratory tract infection
16%
Headache
12%
Aspartate aminotransferace increased
12%
Nausea
12%
Alanine aminotransferace increased
8%
Hypoglycaemia
8%
Anemia
8%
Cough
8%
Diarrhoea
4%
Oropharyngeal pain
4%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A - 35 mg REMD-477
Part A - 70 mg REMD-477
Part A - Matching Placebo
Part B - 35 mg REMD-477
Part B - 70 mg REMD-477
Part B - Matching Placebo

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Volagidemab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,377 Total Patients Enrolled
REMD Biotherapeutics, Inc.Industry Sponsor
6 Previous Clinical Trials
290 Total Patients Enrolled

Media Library

REMD-477 (Glucagon Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04779645 — Phase 2
Type 1 Diabetes Research Study Groups: Placebo Group, GRA (REMD-477) Group
Type 1 Diabetes Clinical Trial 2023: REMD-477 Highlights & Side Effects. Trial Name: NCT04779645 — Phase 2
REMD-477 (Glucagon Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04779645 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there specific qualifications for patient eligibility in this clinical experiment?

"For this medical trial, 30 individuals with diabetes and autoimmune illnesses aged 18 to 65 are being accepted. To qualify for the study applicants must meet a number of criteria, such as having been on an insulin regimen for at least 8 weeks prior to screening, using birth control if applicable, meeting the age range requirement of 18-65 years old, and weighing in at 50 kg or more."

Answered by AI

Does this research endeavor include participants that are younger than 45 years old?

"The qualifications for this trial necessitate that potential participants are between the age of 18 to 65. There is a total of 156 studies conducted with patients younger than 18 and another 179 concerning individuals who exceed the upper limit of 65 years old."

Answered by AI

How many individuals have registered to participate in this medical experiment?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this trial, originally advertised on July 31st 2021, is actively searching for participants. 30 individuals need to be sourced from a single medical facility."

Answered by AI

What safety considerations should be taken into account when utilizing REMD-477?

"REMD-477 is rated a 2 on the safety scale due to its current status as a Phase 2 trial, with evidence indicating some protection from harm but none that suggests efficacy."

Answered by AI

Are there current openings to join this experiment?

"Affirmative. The clinicaltrials.gov page for this trial suggests that it is currently recruiting patients, with the original post being from July 31st 2021 and a recent update occurring on November 9th 2022. A total of 30 participants are required to be enrolled at 1 location."

Answered by AI

What precedent exists for the therapeutic use of REMD-477?

"Presently, 2 clinical trials are being performed to investigate REMD-477; both of these experiments have not yet entered Phase 3. While the majority of studies occur in San Antonio, Texas, there are also two other locations conducting research on this potential remedy."

Answered by AI

Is this experiment a pioneering endeavor in the field?

"The development of REMD-477 began in 2021 and the initial clinical trial was funded by REMD Biotherapeutics, Inc.. Following a successful 30 person Phase 1 assessment, this drug received approval for its second stage of testing. Now two separate trials are ongoing across two cities within one nation."

Answered by AI
~6 spots leftby Dec 2024