Growth hormone for Human Growth Hormone Deficiency

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Human Growth Hormone Deficiency+1 Moregrowth hormone and lirglutide - Drug
Eligibility
18 - 45
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions
  • Human Growth Hormone Deficiency
  • Healthy Subjects

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline to week 1,2, 3 of study arm.

Week 1
AgRP change in GH arm
Week 1
AgRP change in GH vs. GH + liraglutide arms
AgRP change in GH vs. placebo arms
Week 1
AgRP change in liraglutide vs. placebo arms

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Growth hormone
1 of 4
Liraglutide
1 of 4
Growth hormone and liraglutide
1 of 4
Placebo
1 of 4

Active Control

Non-Treatment Group

40 Total Participants · 4 Treatment Groups

Primary Treatment: Growth hormone · Has Placebo Group · Phase 4

Growth hormone
Drug
ActiveComparator Group · 1 Intervention: growth hormone · Intervention Types: Drug
Liraglutide
Drug
ActiveComparator Group · 1 Intervention: liraglutide · Intervention Types: Drug
Growth hormone and liraglutide
Drug
ActiveComparator Group · 1 Intervention: growth hormone and lirglutide · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 1,2, 3 of study arm.

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,299 Previous Clinical Trials
1,620,497 Total Patients Enrolled
7 Trials studying Human Growth Hormone Deficiency
324 Patients Enrolled for Human Growth Hormone Deficiency

Eligibility Criteria

Age 18 - 45 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Half of the subjects possess an overweight/obese medical condition.
You do not take any prescribed drugs or other substances.
Your blood pressure is lower than 140/90 mmHg, Hemoglobin A1c level is below 5.7%, Fasting Plasma Glucose levels are less than 100 mg/dL, Insulin-like Growth Factor 1 and Thyroid Stimulating Hormone levels are normal on screening tests.
Pre-menopausal women must utilize non-hormonal forms of contraception.
You do not currently smoke.
Individuals with GH deficiency.
24 individuals with GH deficiency were studied; 12 male and 12 female.
You are between 18 and 45 years old.