What this trial means for you
This study is recruiting now at 1 US site. It's studying growth hormone and lirglutide, growth hormone, liraglutide, Placebo for healthy, growth hormone deficiency.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: HEALTHY SUBJECTS 1. 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. 2. No medical conditions except being overweight/obese in half of subjects 3. No prescription medication or other drug use 4. On screening testing: BP\<140/\<90 mmHg, HbA1c\<5.7%, FPG\<100 mg/dL, normal IGF-1 and TSH levels. 5. Premenopausal women: use of nonhormonal method of contraception 6. Current non-smoker GH DEFICIENT SUBJECTS 1. 24 patients with isolated GH deficiency:12 males, 12 females. 2. Ages 18-45 years 3. Diagnosis of isolated GH deficiency based on accepted, BMI-appropriate GH stimulation test cut offs within 12 months of enrollment 4. No prior GH therapy within 12 months of study enrollment 5. Normal thyroid, adrenal and gonadal function documented by accepted stimulation test and clinical criteria 6. Premenopausal women: use of nonhormonal method of contraception Exclusion Criteria: HEALTHY SUBJECTS 1. History of malignancy, diabetes, thyroid cancer or pancreatitis 2. Recent dieting, weight change \>5%, pregnancy or lactation or heavy exercise 3. 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 1. DM requiring medication 2. HbA1C \> 7.5 3. Malignancy, pancreatitis or thyroid cancer history. 4. Deficiency of other pituitary hormones, liver or renal disease 5. Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment 5\. Recent dieting, weight change \> 5%, pregnancy, lactation or heavy exercise 6. Current smoking
Study sites by state
New York
- Neuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center — New York · Recruiting now
View the official record on ClinicalTrials.gov →
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