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Hormone

Glucagon Infusion for Obesity (GIO Trial)

Phase 1

Waitlist Available

Led By Steven R Smith, MD

Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-55 years, inclusive

BMI ≥27 to ≤40 kg/m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1, measured at 60 minutes

Awards & highlights

GIO Trial Summary

This trialtested the safety of glucagon, a hormone needed to control blood sugar levels.

Who is the study for?

Adults aged 18-55 with a BMI between 27 and 40, non-diabetic, in good health without significant medical conditions. Participants must not have had weight fluctuations or surgery recently, avoid alcohol, caffeine, strenuous activity before visits, and if female and able to bear children, use birth control.Check my eligibility

What is being tested?

The trial is testing the tolerability of glucagon infusions in obese individuals. It aims to understand how well these participants can tolerate this hormone treatment which could potentially influence body weight regulation.See study design

What are the potential side effects?

While specific side effects are not listed here for glucagon infusion in obese subjects, common ones may include nausea or vomiting due to its effect on blood sugar levels and gastrointestinal motility.

GIO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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My BMI is between 27 and 40.

GIO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1, measured at 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1, measured at 60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1, measured at 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glucagon

GIO Trial Design

1Treatment groups

Experimental Treatment

Group I: Glucagon InfusionExperimental Treatment1 Intervention

Glucagon infusion in escalating manner at 12.5, 25, 37.5 and 50 ng/kg/min (each step for 60 min). At 30 and 60 mins of each infusion rate, we will administer a previously established questionnaire to assess overall nausea intensity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glucagon

2016

Completed Phase 4

~590

0 / 2Eligibility criteria met