Your session is about to expire
← Back to Search
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%
Must not have
Patients must not have received a thiazolidinedione, GLP-1 agonist, or insulin for more than one week during the year prior to randomization
Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 2; more than non-specific ST-T wave changes on the EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 13 weeks
Awards & highlights
Summary
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.
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.
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.
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 belowSelect...
I am a woman not breastfeeding, either post-menopausal, using birth control, or sterilized.
Select...
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%.
Select...
I have been on the same diabetes medication dose for at least 3 months.
Select...
I have Type 2 Diabetes and am either not on medication or only take metformin, sulfonylureas, or SGLT-2 inhibitors.
Select...
I can communicate clearly and can legally consent to participate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't used certain diabetes medications for more than a week in the last year.
Select...
I do not have serious heart, blood vessel, or lung problems.
Select...
I or my family have a history of specific pancreatic or endocrine tumors.
Select...
I am unable to give my written consent voluntarily.
Select...
I do not have any major organ diseases as per my recent tests and exams.
Select...
I have not been treated with GLP-1 receptor agonists or insulin.
Select...
I do not have type 1 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 13 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fasting Plasma glucose (FPG)
Glycated Hemoglobin (HbA1c)
Hepatic insulin sensitivity
+4 moreSide effects data
From 2021 Phase 2 trial • 154 Patients • NCT0311799816%
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Glucagon receptor antagonists and GLP-1 receptor agonists are common treatments for Type 2 Diabetes (T2D) that target different aspects of glucose metabolism. Glucagon receptor antagonists block the glucagon receptor, reducing the effects of elevated plasma glucagon concentrations, which helps lower blood glucose levels by inhibiting gluconeogenesis and glycogenolysis in the liver.
GLP-1 receptor agonists enhance glucose-dependent insulin secretion, delay gastric emptying, regulate postprandial glucagon, and reduce food intake, thereby improving glycemic control and aiding in weight loss. These mechanisms are crucial for managing blood sugar levels and overall metabolic health in T2D patients.
[Glucagon antagonists open a new way in treatment of type 2 diabetes Mellitus].What next after basal insulin? Treatment intensification with lixisenatide in Asian patients with type 2 diabetes mellitus.
[Glucagon antagonists open a new way in treatment of type 2 diabetes Mellitus].What next after basal insulin? Treatment intensification with lixisenatide in Asian patients with type 2 diabetes mellitus.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
471 Previous Clinical Trials
91,885 Total Patients Enrolled
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas Health San Antonio
11 Previous Clinical Trials
1,026 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood sugar levels are not too high, and your HbA1c is not too high either.Your AST (SGOT) level is more than twice the normal limit.I am a woman not breastfeeding, either post-menopausal, using birth control, or sterilized.I have been on the same diabetes medication dose for at least 3 months.I am not pregnant or have had surgery to remove my uterus or ovaries.I or my family have a history of specific pancreatic or endocrine tumors.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 am taking medication that could affect my insulin sensitivity, like steroids or lipase inhibitors.I am a woman who has had a hysterectomy.I do not have any major organ diseases as per my recent tests and exams.My weight has been stable, within 3-4 pounds, for the last three months.I have not been treated with GLP-1 receptor agonists or insulin.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 Type 2 Diabetes and am either not on medication or only take metformin, sulfonylureas, or SGLT-2 inhibitors.Your liver enzyme level (ALT) is more than double the normal range.Your blood creatinine level is higher than 1.8 mg/dl.I do not have type 1 diabetes.I am unable to give my written consent voluntarily.Your hematocrit level is less than 34%.You have a serious mental health condition.You are allergic to humanized antibodies.I can communicate clearly and can legally consent to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Glucagon Receptor Agonist (GRA) REMD-477 group
- Group 2: Placebo group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger