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RECRUITING

NCT05681299

PHASE4

Effects of GH and Lirglutide on AgRP

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

Official title: Effects of Administration of Growth Hormone, Without and With Liraglutide, on AgRP, Energy and Glucose Metabolism in Healthy and GH Deficient Humans

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-05-01

Completion Date

2028-04-30

Last Updated

2026-03-04

Healthy Volunteers

Yes

Conditions

Healthy Growth Hormone Deficiency

Interventions

DRUG

growth hormone and lirglutide

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.

DRUG

growth hormone

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.

DRUG

liraglutide

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.

DRUG

Placebo

Placebo will be taken by nightly subcutaneous injection at 9-11 pm.

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

Locations (1)

Neuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center

New York, New York, United States

Clinical Research Directory

Effects of GH and Lirglutide on AgRP

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)