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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07212868
Phase
PHASE1
Status
Recruiting
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Conditions

  • Non-Diabetic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • REMD-477 versus Placebo — DRUG
    Placebo versus glucagon receptor antagonist using a human monoclonal antibody with a high level of antagonistic effect against human glucagon receptor.
  • Exogenous glucagon versus saline infusion — OTHER
    The effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied.

Study Details

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.

Key Dates

Start date
Feb 25, 2026
Status verified
May 2026
Primary completion
May 1, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Mixed Meal study with and without glucagon receptor antagonist
    Mixed meal test conducted with a sequential design of receiving a single dose subcutaneous injection of glucagon receptor antagonist or placebo.
  • Other: Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion
    A cross-over study to compare the effect of glucagon infusion on glucose metabolism measured during clamp studies

Primary Outcome Measure

Glycemc response to meal ingestion [ Time Frame: 0 to 240 minutes ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Texas Diabetes Institute - University Health SystemSan AntonioTexas78207
Mooney A Mark-Johnson, RN
Marzieh Salehi, MD MS (PRINCIPAL_INVESTIGATOR)
University of Texas San AntonioSan AntonioTexas78229
Matthew A Davis
[email protected]
Mooney Mark-Johnson
[email protected]
Marzieh Salehi, MD, MS (PRINCIPAL_INVESTIGATOR)

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Texas Diabetes Institute - University Health System· San Antonio, TXUniversity of Texas San Antonio· San Antonio, TX