NCT05681299 Effects of GH and Lirglutide on AgRP

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 40 participants in total. It began in 2023-05-01 with a primary completion date of 2028-04-30.

Brief 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.

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

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