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The Effects of Glucagon on Hepatic Metabolism

Plain-language guide to NCT05500586: phase 1, phase 2 non-randomized trial of Glucagon, 21 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05500586
Phase
phase 1, phase 2
Status
completed
Start
2022-10-20
Completion (planned or actual)
2025-09-30
Participants
21 (actual)
Design
non-randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Obesity; Type2diabetes; NAFLD
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 1, phase 2 trial tested Glucagon.

Unfortunately, it is unclear if glucagon resistance is caused by obesity, hepatic steatosis or both.

It had five arms (groups): Healthy Adults (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

In rodents, altered glucagon signaling changes α-cell function and mass - an effect mediated by changes in circulating AA concentrations.

Are the elevated concentrations of branched-chain AA and other AA metabolites in T2DM a cause or an effect of global α-cell dysfunction?

Could altered glucagon signaling precipitate a vicious cycle resulting in T2DM?

Who Took Part

The registry lists 21 actual participants took part.

It was open to people of any sex aged from 25 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI ≥ 28 Kg/M2. Managed by diet alone or a combination of metformin and/or sulfonylurea. Willing to stop glucose-lowering medication for 3 weeks prior to participation and willing to self-monitor their fasting glucose during this time. No history of micro- or macrovascular complications of T2DM.

The full record lists 5 inclusion and 46 exclusion criteria; among the exclusions: age \< 25 or \> 65 years; BMI ≤ 28 Kg/M2; for female subjects: positive pregnancy test at the time of enrollment or study.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Glucagon group and the comparison group ran side by side rather than switching.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-10-20 with completion listed for 2025-09-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Rate of Amino Acid Catabolism in the Presence / Absence of Glucagon (time frame: 0 minutes, 120 minutes, 240 minutes).

It also tracked 3 secondary outcomes, for example Splanchnic Balance of Essential Amino Acids During Fasting and Glucagon Infusion and Splanchnic Balance of Nonessential Amino Acids During Fasting and Glucagon Infusion.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Glucagon in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.