Effects of GH and Lirglutide on AgRP (NCT05681299) | Clinical Trial Compass
RecruitingPhase 4
Effects of GH and Lirglutide on AgRP
United States40 participantsStarted 2023-05-01
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
✓. No medical conditions except being overweight/obese in half of subjects
✓. No prescription medication or other drug use
✓. On screening testing: BP\<140/\<90 mmHg, HbA1c\<5.7%, FPG\<100 mg/dL, normal IGF-1 and TSH levels.
✓. Premenopausal women: use of nonhormonal method of contraception
✓. Current non-smoker
✓. 24 patients with isolated GH deficiency:12 males, 12 females.
✓. Ages 18-45 years
Exclusion criteria
✕
What they're measuring
1
AgRP change in GH vs. placebo arms
Timeframe: Baseline to weeks 1, 2, 3 of each study arm.
2
AgRP change in GH vs. GH + liraglutide arms
Timeframe: Baseline to weeks 1, 2, 3 of each study arm.