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The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
Plain-language guide to NCT07212868: phase 1 non-randomized trial of Glucagon, 150 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07212868
- Phase
- phase 1
- Status
- recruiting participants
- Start
- 2026-02-25
- Completion (planned or actual)
- 2030-05-01
- Participants
- 150 (estimated)
- Design
- non-randomized, single-blind, other
- Conditions studied
- Non-Diabetic
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Glucagon.
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.
The researchers use an investigational drug called REMD 477. "Investigational" means that the has not yet been approved by the U.S.
It had two arms (groups): Mixed Meal study with and without glucagon receptor antagonist (experimental) and Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion (other).
A cross-over study to compare the effect of glucagon infusion on glucose metabolism measured during clamp studies.
The registry classes the interventions as drug and other.
More on the Plan
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.
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.
Who Took Part
The registry lists 150 planned participants were the target.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Provision of signed and dated informed consent form from participant. Male or female, ≤65 and ≥18 years old. Subjects with history of gastric bypass surgery and sleeve gastrectomy more than a year since surgery and non-surgical subjects without history of gastrointestinal (GI) surgery. Willing to adhere to the study intervention regimen. Female subjects of childbearing potential must have a negative pregnancy test at screening and all the study visits, and must not be lactating.
The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: hgb \<11; current gi obstruction or chronic diarrhea; subjects who are not within the age range of 18- 65 years.
How the Study Was Run
It was run as a non-randomized, sequential and single-blind study.
In this single-blind Glucagon study one party knew the assignments and the other did not.
Those kept unaware of assignments: participant.
It started in 2026-02-25 with completion listed for 2030-05-01.
It ran at 2 sites in United States (2).
Its stated primary purpose is other.
What Was Measured
Primary outcome: Glycemic response to meal ingestion (time frame: 0 to 240 minutes). Endogenous glucose production (EGP) during clamp studies (time frame: 0 to 240 minutes).
It also tracked 3 secondary outcomes, for example Prandial glucose kinetics, Plasma GLP-1, GIP, insulin and glucagon concentrations and Glucose clearance and insulin and glucagon concentrations during clamp studies.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Glucagon in 150 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Glucagon compound page, all human trials.
Our Notes on the Compound
Glucagon: A 29-amino-acid pancreatic hormone that raises blood glucose; used as a rescue medicine for severe low blood sugar and as a diagnostic aid.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.