Growth Hormone + Liraglutide for Metabolic Health Improvement
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized, placebo-controlled, cross-over study with 4 arms. Healthy and GH deficient adults ages 18-45 years will be studied. Arms will consist of 21-day treatment periods and be separated by 8-week washout periods. Subjects will receive, in random order: i) GH alone, ii) GH with liraglutide, iii) liraglutide alone and iv) placebo. Each phase of the study will consist of a 7-day baseline period including 2 days of testing and 21 days on therapy with visits on days 2, 7, 14 and 21. Testing before, during and at the completion of each arm will include blood sampling and assessments of insulin resistance, energy expenditure and body composition.
Will I have to stop taking my current medications?
Yes, participants must not be on any prescription medications or drugs that could affect growth hormone or IGF-1 levels, or for weight loss, within 6 months of enrollment.
Is the combination of Growth Hormone and Liraglutide generally safe for humans?
Growth hormone (GH) has been used safely for over 40 years, with a wide safety margin, though it requires monitoring for side effects like swelling, increased blood sugar, and other rare conditions. No data suggests GH increases cancer risk, and studies show no significant adverse effects in children treated with GH.12345
What makes the Growth Hormone + Liraglutide drug unique for metabolic health improvement?
This treatment combines growth hormone (which helps with growth and metabolism) and liraglutide (a medication that can help with weight loss and blood sugar control), offering a novel approach by targeting both growth and metabolic pathways simultaneously, which is different from using either component alone.12678
What data supports the effectiveness of the drug Growth Hormone + Liraglutide for improving metabolic health?
Research shows that growth hormone treatment can reduce body fat, increase lean body mass, and improve metabolic health in adults with growth hormone deficiency. Additionally, growth hormone has been effective in reducing visceral fat in patients with certain conditions, suggesting potential benefits for metabolic health.89101112
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
7-day baseline period including 2 days of testing
Treatment
Participants receive nightly subcutaneous injections of study medications or placebo for 21 days
Washout
8-week washout period between treatment arms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Growth Hormone
- Growth Hormone and Liraglutide
- Liraglutide
- Placebo
Growth Hormone is already approved in United States, European Union, Canada for the following indications:
- Growth hormone deficiency
- Turner syndrome
- Prader-Willi syndrome
- Chronic kidney disease
- Short stature due to Noonan syndrome
- Short stature due to Turner syndrome
- HIV-associated wasting
- Growth hormone deficiency
- Turner syndrome
- Prader-Willi syndrome
- Chronic kidney disease
- Short stature due to Noonan syndrome
- Short stature due to Turner syndrome
- Growth hormone deficiency
- Turner syndrome
- Prader-Willi syndrome
- Chronic kidney disease
- Short stature due to Noonan syndrome
- Short stature due to Turner syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor