40 Participants Needed

Growth Hormone + Liraglutide for Metabolic Health Improvement

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PU
Overseen ByPamela U. Freda, MD
Prior Safety DataThis treatment has passed at least one previous human trial

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

Current non-smoker
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.
See 9 more

Exclusion Criteria

I do not have other pituitary, liver, or kidney diseases.
I have a history of cancer, diabetes, thyroid issues, or pancreatitis.
Recent dieting, weight change >5%, pregnancy or lactation or heavy exercise
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

7-day baseline period including 2 days of testing

1 week
2 visits (in-person)

Treatment

Participants receive nightly subcutaneous injections of study medications or placebo for 21 days

3 weeks
4 visits (in-person) on days 2, 7, 14, and 21

Washout

8-week washout period between treatment arms

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Growth Hormone
  • Growth Hormone and Liraglutide
  • Liraglutide
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
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.

Growth Hormone is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Somatropin for:
  • 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
🇪🇺
Approved in European Union as Somatropin for:
  • Growth hormone deficiency
  • Turner syndrome
  • Prader-Willi syndrome
  • Chronic kidney disease
  • Short stature due to Noonan syndrome
  • Short stature due to Turner syndrome
🇨🇦
Approved in Canada as Somatropin for:
  • 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

Trials
1,529
Recruited
2,832,000+

Published Research Related to This Trial

A study involving 135 adults with adult growth hormone deficiency (AGHD) found that both depot growth hormone (GH) given every 14 days and daily GH injections significantly reduced trunk and visceral fat, with the depot form showing a 3.2% decrease in trunk fat compared to no treatment.
Both treatment methods increased lean body mass and had similar side effect profiles, indicating that the depot GH is as safe and effective as daily injections for managing AGHD.
Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency.Hoffman, AR., Biller, BM., Cook, D., et al.[2016]
Recombinant human growth hormone (r-hGH) significantly reduces visceral adipose tissue (VAT) in HIV-1-infected patients with lipodystrophy, showing a 29% reduction at 12 weeks and nearly 40% at 24 weeks, based on a study of 26 subjects.
While r-hGH treatment led to an increase in high-density lipoprotein (HDL) levels, it also caused transient and reversible side effects, which were more common in patients receiving daily doses compared to those receiving it three times a week.
A randomized, open-label study to compare the effects of two different doses of recombinant human growth hormone on fat reduction and fasting metabolic parameters in HIV-1-infected patients with lipodystrophy.Bickel, M., Zangos, S., Jacobi, V., et al.[2006]
In a study of 60 patients with adult growth hormone deficiency (AGHD), higher levels of visceral adipose tissue (VAT) were linked to worse metabolic health, indicating that VAT is a significant metabolic risk factor for these patients.
After one year of growth hormone treatment, patients showed a reduction in VAT and partial improvements in lipid profiles, such as increased HDL and decreased triglycerides, although glucose metabolism remained largely unchanged.
Body fat distribution and circulating adipsin are related to metabolic risks in adult patients with newly diagnosed growth hormone deficiency and improve after treatment.Wang, Y., Zheng, X., Xie, X., et al.[2021]

Citations

Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency. [2016]
A randomized, open-label study to compare the effects of two different doses of recombinant human growth hormone on fat reduction and fasting metabolic parameters in HIV-1-infected patients with lipodystrophy. [2006]
Body fat distribution and circulating adipsin are related to metabolic risks in adult patients with newly diagnosed growth hormone deficiency and improve after treatment. [2021]
User assessment of Norditropin NordiFlex(®), a new prefilled growth hormone pen: a Phase IV multicenter prospective study. [2022]
Growth hormone deficiency in adults: the role of replacement therapy. [2018]
A randomized, double-blind study to assess the efficacy and safety of valtropin, a biosimilar growth hormone, in children with growth hormone deficiency. [2007]
Long-term safety and efficacy of Omnitrope® in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study. [2018]
Safety and efficacy of growth hormone therapy in childhood. [2008]
Maintaining persistence and adherence with subcutaneous growth-hormone therapy in children: comparing jet-delivery and needle-based devices. [2022]
[Results of the treatment of growth hormone deficiency with methionine-somatotropin or recombinant somatotropin]. [2006]
11.United Statespubmed.ncbi.nlm.nih.gov
Long-term safety and efficacy of the recombinant human growth hormone Omnitrope® in the treatment of Spanish growth hormone deficient children: results of a phase III study. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Rationale and design of PATRO Adults, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope(®) for the treatment of adult patients with growth hormone deficiency. [2021]
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