Actively Recruiting
Effects of GH and Lirglutide on AgRP
Led by Columbia University · Updated on 2026-03-04
40
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of GH and Lirglutide on AgRP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 45 years
- Healthy subjects: 40 adults equally split by gender; half overweight or Class 1 obese with abdominal fat, half lean without central adiposity
- Healthy subjects must have no medical conditions except overweight/obesity in half
- Healthy subjects must have blood pressure below 140/90 mmHg, HbA1c below 5.7%, fasting plasma glucose below 100 mg/dL, and normal IGF-1 and TSH levels
- Healthy premenopausal women must use nonhormonal contraception
- Healthy subjects must be current non-smokers
- GH deficient subjects: 24 adults equally split by gender with isolated GH deficiency diagnosed within 12 months
- GH deficient subjects must have no prior GH therapy in the past 12 months
- GH deficient subjects must have normal thyroid, adrenal, and gonadal function
- GH deficient premenopausal women must use nonhormonal contraception
You will not qualify if you...
- Healthy subjects with history of malignancy, diabetes, thyroid cancer, or pancreatitis
- Healthy subjects with recent dieting, weight change over 5%, pregnancy, lactation, or heavy exercise
- Healthy subjects using glucocorticoids, hormonal supplements, or medications affecting GH, IGF-1, or weight loss within 6 months
- GH deficient subjects with diabetes requiring medication
- GH deficient subjects with HbA1c above 7.5
- GH deficient subjects with history of malignancy, pancreatitis, or thyroid cancer
- GH deficient subjects with other pituitary hormone deficiencies, liver or kidney disease
- GH deficient subjects using glucocorticoids, hormonal supplements, or medications affecting GH, IGF-1, or weight loss within 6 months
- GH deficient subjects with recent dieting, weight change over 5%, pregnancy, lactation, or heavy exercise
- Current smokers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Neuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
P
Pamela Freda, MD
CONTACT
R
Rosa Lazarte
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
4
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