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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
GIO B Trial 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.Check my eligibility
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.See study design
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.
GIO B Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
GIO B Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of continuous IV infusion of glucagon versus placebo
Energy Expenditure
GIO B 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
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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
3,567 Total Patients Enrolled
11 Trials studying Obesity
339 Patients Enrolled for Obesity
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,151 Total Patients Enrolled
11 Trials studying Obesity
339 Patients Enrolled for Obesity
Steven Smith, MDPrincipal InvestigatorStudy Principal Investigator
3 Previous Clinical Trials
16,122 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can avoid drinking alcohol for 2 days before my study visit.I haven't taken weight or metabolism affecting drugs in the last 3 months, except for stable hormone therapy.You have used illegal drugs or nicotine products in the past three months before screening.I am not pregnant, breastfeeding, or planning to become pregnant and will use birth control.I am between 18 and 55 years old.I haven't taken SSRIs, depression meds, or apomorphine in the last week.I have had weight loss surgery in the past.I have diabetes, thyroid issues, or other specific hormone-related conditions.I have a history of irritable bowel disease or often feel nauseous or vomit.Your heart is beating faster than normal (more than 100 beats per minute) during screening.My kidney function is reduced, with specific test results showing it.I have a history of HBV, HCV, or HIV infection.I do not have serious heart problems or recent major heart events.I have been diagnosed with sleep apnea and may or may not be using a CPAP/BiPAP/AutoPAP machine.I have not had major surgery in the last 3 months.I do not have significant liver, kidney, lung, heart, cancer, metabolic, stomach, or blood diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Glucagon High Dose
- Group 2: Glucagon Low Dose
- Group 3: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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