Effects of growth hormone and liraglutide on appetite regulation

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

This study is testing if growth hormone and liraglutide can change appetite-related hormones in healthy adults and those with growth hormone deficiency to see how they affect weight and energy use.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Columbia University (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05681299 on ClinicalTrials.gov

What this trial studies

This interventional study investigates the impact of growth hormone (GH) and liraglutide on the orexigenic neuropeptide AgRP in healthy adults and those with growth hormone deficiency. Participants aged 18-45 will undergo a randomized, placebo-controlled, cross-over design with four treatment arms: GH alone, GH with liraglutide, liraglutide alone, and placebo, each lasting 21 days with an 8-week washout period. The study will assess changes in insulin resistance, energy expenditure, and body composition through blood sampling and various tests before, during, and after each treatment phase. The goal is to determine whether GH stimulates AgRP levels and how liraglutide may influence this relationship.

Who should consider this trial

Good fit: Ideal candidates include healthy adults and those with isolated growth hormone deficiency aged 18-45, with specific BMI and waist circumference criteria.

Not a fit: Patients with significant medical conditions, those on prescription medications, or individuals outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into new treatments for metabolic disorders related to growth hormone deficiency and appetite regulation.

How similar studies have performed: While the specific interaction of GH and AgRP in humans is novel, related studies have shown promising results in understanding the metabolic effects of growth hormone.

Eligibility criteria

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

Where this trial is running

New York, New York

• Neuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Pamela Freda, MD

Conditions: Healthy, Growth Hormone Deficiency, growth hormone, liraglutide, AgRP