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Hormone Therapy
Growth Hormone + Liraglutide for Metabolic Health Improvement
Phase 4
Recruiting
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 1,2, 3 of study arm.
Awards & highlights
Summary
This trial will test the effects of Growth Hormone & Liraglutide on adults to measure insulin resistance, energy expenditure & body composition.
Who is the study for?
Adults aged 18-45, both healthy and those with growth hormone deficiency, can join this trial. Healthy participants should be either overweight or lean without serious medical conditions. GH deficient subjects must not have had prior GH therapy for a year and need normal thyroid and adrenal function.Check my eligibility
What is being tested?
The study tests the effects of growth hormone (GH) alone, liraglutide alone, both combined, and placebo on metabolism in adults. It's a randomized study where each participant tries all treatments in different periods with breaks in between.See study design
What are the potential side effects?
Possible side effects include changes to blood sugar levels, insulin resistance alterations, potential digestive issues from liraglutide, and reactions at injection sites for both medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 1,2, 3 of study arm.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 1,2, 3 of study arm.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AgRP change in GH vs. GH + liraglutide arms
AgRP change in GH vs. placebo arms
Secondary outcome measures
AgRP change in GH arm
AgRP change in liraglutide vs. placebo arms
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Growth hormone and liraglutideActive Control1 Intervention
GH will be administered as one nightly subcutaneous self-injection at 11pm at a dose of 0.03 mg/kg/day in healthy and 0.5 mg in male and 0.6 mg in female GHD subjects. Liraglutide will be administered by subcutaneous injection taken by subjects beginning at a dose at 0.6 mg nightly from 9-11 pm and escalated in 0.6 mg increments weekly as tolerated to a final dose of 1.8 mg nightly.
Injections will be performed from the night of day 0 to the night of day 20.
Group II: Growth hormoneActive Control1 Intervention
GH will be administered as one nightly subcutaneous self-injection at 11pm at a dose of 0.03 mg/kg/day in healthy and 0.5 mg in male and 0.6 mg in female GHD subjects. Injections will be performed from the night of day 0 to the night of day 20.
Group III: LiraglutideActive Control1 Intervention
Liraglutide will be administered by subcutaneous injection taken by subjects beginning at a dose at 0.6 mg nightly from 9-11 pm and escalated in 0.6 mg increments weekly as tolerated to a final dose of 1.8 mg nightly. Injections will be performed from the night of day 0 to the night of day 20.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo will be administered as one nightly subcutaneous self-injection at 9-11pm from the night of day 0 to the night of day 20.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,448 Previous Clinical Trials
2,531,450 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have other pituitary, liver, or kidney diseases.I have a history of cancer, diabetes, thyroid issues, or pancreatitis.I haven't taken steroids, hormones, or weight loss drugs in the last 6 months.I have growth hormone deficiency and need medication for diabetes.I am overweight or mildly obese with a high waist circumference.I am overweight with a BMI between 25-34.9 and have a waist size of at least 102 cm if male, or 88 cm if female.I am overweight/obese with no other medical conditions.I have been diagnosed with growth hormone deficiency in the last year.I am lean with a BMI between 19 and 24.9 and do not meet the waist circumference criteria.I haven't taken growth hormone therapy in the last year.I am not taking any prescription medications or drugs.My thyroid, adrenal, and reproductive glands are functioning normally.I am one of 24 patients with a specific growth hormone deficiency.I have a history of cancer, pancreatitis, or thyroid cancer.I am a healthy individual, aged 18-45.I have been diagnosed with isolated growth hormone deficiency.I am between 18 and 45 years old.I am healthy, aged 18-45, and fit the gender requirement.I am lean with a BMI between 19 and 24.9 and do not meet the waist circumference criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Growth hormone and liraglutide
- Group 2: Growth hormone
- Group 3: Liraglutide
- Group 4: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
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