What this study is
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.
What's being tested
- growth hormone and lirglutide
Intervention · DRUG
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 and 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.
- growth hormone
Intervention · DRUG
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
Intervention · DRUG
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.
- Placebo
Intervention · DRUG
Placebo will be taken by nightly subcutaneous injection at 9-11 pm.
Study details
- Official title
- Effects of Administration of Growth Hormone, Without and With Liraglutide, on AgRP, Energy and Glucose Metabolism in Healthy and GH Deficient Humans
- Sponsor
- Columbia University
- Conditions
- Healthy · Growth Hormone Deficiency
- Enrolling
- 40 people
- Starts
- 2023-05-01
- Est. completion
- 2028-04-30
- Design
- Single-blind, randomized, sequential groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- HEALTHY SUBJECTS
- 40 healthy subjects, 20 male, 20 female, ages 18-45 yr.: (i) 20 (10 male, 10 female) who are overweight/Class 1 Obese (BMI 25-34.9) with abdominal fat accumulation (central adiposity) defined by waist circumference (WC) ≥ 102 cm in men, ≥ 88 cm in women, except in East/South Asians for whom the criteria will be WC ≥ 90 men and ≥ 80 women; (ii) 20 (10 male,10 female) who are lean (BMI 19-24.9) and not meeting these WC criteria.
- No medical conditions except being overweight/obese in half of subjects
- No prescription medication or other drug use
- On screening testing: BP<140/<90 mmHg, HbA1c<5.7%, FPG<100 mg/dL, normal IGF-1 and TSH levels.
- Premenopausal women: use of nonhormonal method of contraception
- Current non-smoker GH DEFICIENT SUBJECTS
- 24 patients with isolated GH deficiency:12 males, 12 females.
- Ages 18-45 years
- Diagnosis of isolated GH deficiency based on accepted, BMI-appropriate GH stimulation test cut offs within 12 months of enrollment
- No prior GH therapy within 12 months of study enrollment
- Normal thyroid, adrenal and gonadal function documented by accepted stimulation test and clinical criteria
- Premenopausal women: use of nonhormonal method of contraception
You can't join if
- HEALTHY SUBJECTS
- History of malignancy, diabetes, thyroid cancer or pancreatitis
- Recent dieting, weight change >5%, pregnancy or lactation or heavy exercise
- Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment GH DEFICIENT SUBJECTS
- DM requiring medication
- HbA1C > 7.5
- Malignancy, pancreatitis or thyroid cancer history.
- Deficiency of other pituitary hormones, liver or renal disease
- Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment
- Recent dieting, weight change > 5%, pregnancy, lactation or heavy exercise 6. Current smoking
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNeuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center
New York, New York, United States
- Pamela U. Freda, MD · Contact212-305-2254
- Carlos M. Reyes-Vidal, MD · Contact212-305-4921csr52@cumc.columbia.edu
Recruiting
Study team
Sponsor
Columbia University
Study ID AAAU4280
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.