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Glucagon Receptor Antagonist

REMD-477 for Type 2 Diabetes

Phase < 1
Waitlist Available
Led By Ralph DeFronzo, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Type 2 diabetic subjects, males/females, age = 18-70 years, BMI = 25-40 kg/m2, HbA1c = 7.5-10.0%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 13 weeks
Awards & highlights

Study Summary

This trial will help to understand how glucagon affects diabetes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site due to subcutaneous administration of REMD-477 or placebo. As with many drugs targeting metabolic processes, there could also be risks related to blood sugar levels and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman not breastfeeding, either post-menopausal, using birth control, or sterilized.
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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%.
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I have been on the same diabetes medication dose for at least 3 months.
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I have Type 2 Diabetes and am either not on medication or only take metformin, sulfonylureas, or SGLT-2 inhibitors.
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I can communicate clearly and can legally consent to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 13 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
Fasting Plasma glucose (FPG)
Glycated Hemoglobin (HbA1c)
Hepatic insulin sensitivity
+4 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: 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REMD-477
2021
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,390 Total Patients Enrolled
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas Health San Antonio
11 Previous Clinical Trials
1,090 Total Patients Enrolled

Media Library

REMD-477 (Glucagon Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05093517 — Phase < 1
Type 2 Diabetes Research Study Groups: Glucagon Receptor Agonist (GRA) REMD-477 group, Placebo group
Type 2 Diabetes Clinical Trial 2023: REMD-477 Highlights & Side Effects. Trial Name: NCT05093517 — Phase < 1
REMD-477 (Glucagon Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05093517 — Phase < 1

Frequently Asked Questions

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

What is the usual application of REMD-477?

"REMD-477 has been demonstrated to be effective for managing type 2 diabetes mellitus, diabetes, and hypoglycemia."

Answered by AI

Am I eligible to participate in this trial?

"This medical trial seeks 24 participants aged between 18 and 70 with type 2 diabetes mellitus who meet the following criteria: Drug free or taking metformin, sulfonylureas, SGLT-2 inhibitors; BMI of 25-40 kg/m2; Non-lactating postmenopausal females two years past menopause or using approved contraceptive methods; Hysterectomy patients eligible. All female participants must have a negative pregnancy test throughout the duration of the study."

Answered by AI

Is this test still recruiting participants?

"The information found on clinicaltrials.gov reveals this medical trial is currently seeking participants. The registration date was November 10th 2021, with the most recent update being issued December 22nd 2021."

Answered by AI

What is the aggregate number of participants involved in this trial?

"That is correct. According to the information available on clinicaltrials.gov, this medical trial was first posted on November 10th 2021 and has been actively searching for candidates since then. In total, 24 volunteers are needed from one site for this experiment."

Answered by AI

Does this study accept participants of a certain age range, such as those under 35?

"This trial is researching participants over the age of 18 and below 70 years old."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Texas Diabetes Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM
2021. "Effect of Novel Glucagon Receptor Antagonist REMD-477 on Glucose and Adipocyte Metabolism in T2DM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05093517.
~1 spots leftby Jun 2024
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