Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07212868

The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
The University of Texas Health Science Center at San Antonio · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The goal of this study is to understand the role of glucagon signal on glucose metabolism in individuals with and without bariatric surgery. The study is involved with measuring glucose metabolism with glucagon infusion and glucagon receptor blockade. We use an investigational drug called REMD 477. "Investigational" means that the has not yet been approved by the U.S. Food \& Drug Administration (FDA). REMD-477 is a monoclonal antibody (an antibody made by cloning a unique white blood cell) that blocks the effect of glucagon.

Detailed description

Participants will be screened, and if eligible will be enrolled for metabolic studies for two separate aims. In aim 1, they undergo glucose clamp study with and without glucagon infusion. In aim 2, they undergo 2-day meal studies with and without a single dose administration of investigational drug, REMD 477 using a small needle subcutaneously. During these studies glycemic profile will be evaluated using CGM (Continuous glucose monitoring). Participants will also have a blood draw for liver enzymes8 weeks after the administration of REMD 477. Participants will spend up to 3- 6 months participating in any pair study.

Conditions

Interventions

TypeNameDescription
DRUGREMD-477 versus PlaceboPlacebo versus glucagon receptor antagonist using a human monoclonal antibody with a high level of antagonistic effect against human glucagon receptor.
OTHERExogenous glucagon versus saline infusionThe effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied.

Timeline

Start date
2026-02-25
Primary completion
2030-05-01
Completion
2030-06-30
First posted
2025-10-08
Last updated
2026-03-12

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07212868. Inclusion in this directory is not an endorsement.