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Hormone Therapy

Glucagon for Obesity (GIO B Trial)

Phase 1
Waitlist Available
Led By Steven 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
Be between 18 and 65 years old
Must not have
Female subjects who are, or intend to become, pregnant during the course of this study, are currently breastfeeding, or women of child-bearing potential (WOCBP) who refuse to use at least one method of birth control (oral contraceptives, intrauterine device, implanted or injectable contraceptives, abstinence)
History of bariatric surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing if a hormone can help obese people lose weight by boosting their metabolism.

Who is the study for?
This trial is for healthy, non-diabetic obese adults aged 18-55 with a BMI of 27 to 45 kg/m2 and stable weight. Participants must not have significant health issues, take certain medications affecting weight or energy metabolism, or have had bariatric surgery. They should not be pregnant, breastfeeding, or unwilling to use birth control if applicable.
What is being tested?
The study tests the effects of glucagon versus placebo on energy expenditure over a period of 72 hours in obese individuals. It aims to understand how prolonged glucagon administration can influence calorie burning in the body without any dietary changes.
What are the potential side effects?
Potential side effects may include reactions at the injection site, nausea due to increased glucose levels in blood (hyperglycemia), and possible low blood sugar (hypoglycemia) if too much insulin is released in response.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, or planning to become pregnant and will use birth control.
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I have had weight loss surgery in the past.
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I have diabetes, thyroid issues, or other specific hormone-related conditions.
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I have a history of irritable bowel disease or often feel nauseous or vomit.
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My kidney function is reduced, with specific test results showing it.
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I have a history of HBV, HCV, or HIV infection.
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I do not have serious heart problems or recent major heart events.
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I have been diagnosed with sleep apnea and may or may not be using a CPAP/BiPAP/AutoPAP machine.
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I have not had major surgery in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effects of continuous IV infusion of glucagon versus placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Glucagon High DoseActive Control1 Intervention
Group II: Glucagon Low DoseActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,634 Total Patients Enrolled
11 Trials studying Obesity
339 Patients Enrolled for Obesity
AdventHealth Translational Research InstituteLead Sponsor
50 Previous Clinical Trials
5,934 Total Patients Enrolled
12 Trials studying Obesity
409 Patients Enrolled for Obesity
Steven Smith, MDPrincipal InvestigatorStudy Principal Investigator
3 Previous Clinical Trials
1,545 Total Patients Enrolled

Media Library

Glucagon (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03139305 — Phase 1
Obesity Research Study Groups: Glucagon High Dose, Glucagon Low Dose, Placebo
Obesity Clinical Trial 2023: Glucagon Highlights & Side Effects. Trial Name: NCT03139305 — Phase 1
Glucagon (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03139305 — Phase 1
~4 spots leftby Dec 2025
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