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
| Type | Name | Description |
|---|---|---|
| DRUG | REMD-477 versus Placebo | Placebo versus glucagon receptor antagonist using a human monoclonal antibody with a high level of antagonistic effect against human glucagon receptor. |
| OTHER | Exogenous glucagon versus saline infusion | The 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07212868. Inclusion in this directory is not an endorsement.