Growth Hormone + Liraglutide for Metabolic Health Improvement

Overseen By Pamela U. Freda, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Columbia University

Must not be taking: Glucocorticoids, Hormonal supplements

Disqualifiers: Diabetes, Malignancy, Pancreatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if growth hormone (a hormone therapy) and liraglutide (an injection) can improve metabolic health by boosting energy use and managing body fat. Participants will try different combinations of these treatments along with a placebo to identify the most effective approach. The trial seeks healthy adults and those with growth hormone deficiency who face challenges like being overweight or having extra abdominal fat. Healthy individuals aged 18 to 45 who are not on medication may be suitable candidates. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

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.

What is the safety track record for these treatments?

Research has shown that growth hormone (GH) treatment has been studied for safety, particularly in children. It is generally well-tolerated, but it can sometimes cause changes in metabolism. Some studies have reported new or recurring non-cancerous and cancerous tumors, highlighting the importance of monitoring these possibilities during treatment.

For liraglutide, studies have shown mixed results. Some found it effective and safe, while others raised concerns about possible risks. Notably, there is a chance of developing thyroid tumors, including thyroid cancer, especially at high doses. However, studies on type 2 diabetes treatment with liraglutide did not show an increased risk of major heart-related problems.

Combining GH with liraglutide hasn't been specifically studied for safety. However, since both treatments have been individually researched, their separate safety profiles should be considered. Participants should be aware of the potential risks involved with each treatment and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the combination of Growth Hormone (GH) and Liraglutide for improving metabolic health because it targets two key areas: hormone regulation and appetite control. Unlike standard treatments that typically focus on just one aspect, this combination leverages GH for its role in metabolism and tissue growth, while Liraglutide, an incretin mimetic, helps regulate appetite and glucose levels. This dual approach could offer a more comprehensive solution, potentially leading to faster and more effective metabolic improvements compared to existing single-treatment options.

What evidence suggests that this trial's treatments could be effective for metabolic health improvement?

Research has shown that both growth hormone (GH) and liraglutide can improve metabolic health. In this trial, participants may receive GH alone, liraglutide alone, or a combination of both. Liraglutide has proven effective for weight loss, with studies indicating some patients lose up to 10% of their body weight and achieve better metabolic control. GH therapy is associated with stronger bones and increased muscle mass, though it might also cause weight gain. Early research suggests that using GH and liraglutide together may enhance body composition and metabolism more effectively than either treatment alone. Existing evidence supports the benefits of these treatments. ^{6 7 8 9 10}

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

I haven't taken growth hormone therapy in the last year.

I have been diagnosed with growth hormone deficiency in the last year.

On screening testing: BP<140/<90 mmHg, HbA1c<5.7%, FPG<100 mg/dL, normal IGF-1 and TSH levels

Exclusion Criteria

I do not have other pituitary, liver, or kidney diseases.

I haven't taken steroids, hormones, or weight loss drugs in the last 6 months.

Recent dieting, weight change >5%, pregnancy or lactation or heavy exercise

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?

Group I: Growth hormone and liraglutide Active Control 1 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 hormone Active Control 1 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: Liraglutide Active Control 1 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: Placebo Placebo Group 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a long-acting growth hormone (GH) preparation in patients with adult GH deficiency. Hoffman, AR., Biller, BM., Cook, D., et al.[2016]

In a phase III study involving 70 prepubertal children with growth hormone deficiency, long-term treatment with Omnitrope (0.03 mg/kg/day) resulted in significant growth improvements over 4 years, including an average height increase of 31.1 cm.

Omnitrope was found to be safe and well tolerated, with significant increases in serum levels of IGF-1 and IGFBP-3, indicating effective stimulation of growth-related hormones.

NCBI (Pubmed)

pubmed.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. López-Siguero, J., Borrás Pérez, MV., Balser, S., et al.[2013]

Children using the ZomaJet jet-delivery device for growth hormone therapy showed significantly longer persistence in treatment (599 days) compared to those using needle-based devices (535 days), indicating better adherence to therapy.

The majority of children using ZomaJet (58%) were classified as adherent, suggesting that this delivery method may improve medication-taking behaviors and potentially lead to better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining persistence and adherence with subcutaneous growth-hormone therapy in children: comparing jet-delivery and needle-based devices. Spoudeas, HA., Bajaj, P., Sommerford, N.[2022]

Recent studies have shown that replacement therapy with recombinant human growth hormone (rhGH) can significantly improve health outcomes in adults with growth hormone deficiency, including reduced cardiovascular risk, better lipid profiles, and enhanced psychological well-being.

Despite these benefits, there are still unresolved issues regarding long-term treatment, such as the potential risks of malignancy and impaired glucose tolerance, indicating that somatropin therapy should be closely monitored and conducted alongside clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth hormone deficiency in adults: the role of replacement therapy. Meling, TR.[2018]

Growth hormone (GH) has been effectively used for over 40 years to improve height velocity in children with growth impairments and to correct metabolic issues related to GH deficiency, supported by extensive efficacy and safety data.

While GH has a wide safety margin, it can cause side effects such as pseudotumor cerebri and hyperglycemia, necessitating careful monitoring, especially in patients with higher risks for adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of growth hormone therapy in childhood. Bowlby, DA., Rapaport, R.[2008]

In a Phase IV study involving 103 children aged 6 to 17, Norditropin NordiFlex was found to be significantly easier to use than previous growth hormone therapy devices, with a median ease-of-use score of 7.5 (P < 0.001).

Approximately 64.4% of patients preferred Norditropin NordiFlex, and 41% were able to self-inject, indicating that this device may enhance patient autonomy and improve adherence to growth hormone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User assessment of Norditropin NordiFlex(®), a new prefilled growth hormone pen: a Phase IV multicenter prospective study. Tauber, M., Jaquet, D., Jesuran-Perelroizen, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 year-long study involving 16 children with growth hormone deficiency, both methionyl-somatotropin (Somatonorm) and recombinant-somatotropin (Genotropin) significantly improved growth rates, with no significant difference between the two treatments.

While no serious adverse effects were reported, four children treated with Somatonorm developed low levels of antibodies against growth hormone, whereas none of the children receiving Genotropin showed this response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of the treatment of growth hormone deficiency with methionine-somatotropin or recombinant somatotropin]. Dorantes-Alvarez, LM.[2006]

The PATRO Adults study is a large, long-term observational study designed to assess the safety and efficacy of somatropin (Omnitrope(®)) in adults with growth hormone deficiency, involving multiple centers across Europe.

This study will provide valuable insights into the long-term effects of Omnitrope(®) on various health factors, including diabetes development, tumor recurrence, and overall quality of life, while monitoring adverse events and safety outcomes.

NCBI (Pubmed)

pubmed.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. Beck-Peccoz, P., Minuto, F., Leal-Cerro, A., et al.[2021]

Valtropin, a new biosimilar recombinant human growth hormone, demonstrated comparable efficacy to Humatrope in increasing height velocity in children with growth hormone deficiency, with a height velocity of 11.3 cm/year for Valtropin versus 10.5 cm/year for Humatrope over one year.

Both treatments showed similar safety profiles, with no significant differences in adverse events or bone maturation acceleration, indicating that Valtropin is a safe and effective option for treating children with growth hormone deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind study to assess the efficacy and safety of valtropin, a biosimilar growth hormone, in children with growth hormone deficiency. Peterkova, V., Arslanoglu, I., Bolshova-Zubkovskaya, E., et al.[2007]

In a study of 67 Italian patients with growth hormone deficiency, Omnitrope® was found to be effective in improving health markers like insulin-like growth factor-1 levels and body composition over an average treatment duration of 45.4 months.

While 55.2% of patients experienced adverse events, none were deemed related to Omnitrope®, indicating that it is generally safe for long-term use in adults with growth hormone deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of Omnitrope&#174; in adults with growth hormone deficiency: Italian interim analysis of the PATRO Adults study. Ferone, D., Profka, E., Gasco, V., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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Trends In Reported Outcomes for Growth Hormone Therapy In ... Of the 342 different outcomes, 178 (52%) were considered as outcomes that were mainly focused on safety, 94 (28%) on efficacy, and 70 (20%) on ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7245490/

GROWTH HORMONE (GH): USAGE AND ABUSE - PMC In particular, with such treatment patients may experience improved bone mineralization and improved growth (23). - Prader-Willi syndrome. Preliminary findings ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11983003/

Recombinant growth hormone improves growth and adult height Our findings demonstrate that rhGH treatment effectively improves the final height SDS and height SDS gain in children with IGHD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1096637423000229

Metabolic and quality of life effects of growth hormone ... Six months of GHRT was found to significantly improve LBM, cognition, and symptoms related to PTSD despite also increasing body weight and fat mass. Future ...

5. cda-amc.ca cda-amc.ca/sites/default/files/cdr/clinical/SR0333_GenotropinGHD-P_CL_Report_e.pdf

Clinical Review Report: somatropin (Genotropin) for ... improvement in height outcomes were observed in somatropin-treated patients. ... height data and other important health outcomes,. i.e., QoL. GHD = growth ...

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Safety of Pediatric rhGH Therapy: An Overview and ... This review intends to provide a detailed overview of the main studies reporting long-term safety in subjects treated with rhGH therapy during childhood.

7. hpo-docs.jh.edu hpo-docs.jh.edu/EubuGLSW

Growth Hormone Products Somatropin Genotropin Humatrope ... Seven Years of Safety and Efficacy of the Recombinant Human Growth Hormone Omnitrope in the. Treatment of Growth Hormone Deficient Children ...

8. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/oct-2023-durb-agenda-item4q.pdf

Growth Hormone New onsets and reoccurrence of benign and cancerous neoplasms have also been reported. Metabolic complications may be seen occasionally during ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28001454/

Metabolic Health and Long-Term Safety of Growth ... GH-treated SRS patients have a similar metabolic health and safety profile as non-SRS subjects born SGA, both during and until 2 years after GH-stop.

10. hca.wa.gov hca.wa.gov/assets/program/dur-endocrine-and-metabolic-agents-growth-hormones-pol-2025-04-16.pdf

Human Growth Hormone Per package insert, there is no safety or efficacy data available from controlled studies in which patients were treated with Serostim ...