Effects of GH and Lirglutide on AgRP
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorColumbia University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
History of malignancy, diabetes, thyroid cancer or pancreatitis
Recent dieting, weight change >5%, pregnancy or lactation or heavy exercise
Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment
DM requiring medication
Trial design
Design model
Sequential
Treatments tested in this trial
growth hormone and lirglutide
DrugGH 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.
growth hormone
DrugGH 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.
liraglutide
DrugLiraglutide 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.
Placebo
DrugPlacebo will be taken by nightly subcutaneous injection at 9-11 pm.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Growth hormoneActive comparator 1 intervention
Group B: LiraglutideActive comparator 1 intervention
Group C: Growth hormone and liraglutideActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
AgRP change in GH vs. placebo arms
Difference in percent change in morning fasting level of AgRP (agouti-related peptide) in plasma in GH vs. placebo arms.
Time frame
Baseline to weeks 1, 2, 3 of each study arm.2
AgRP change in GH vs. GH + liraglutide arms
Difference in percent change in morning fasting level of AgRP in plasma in GH vs. GH+liraglutide arms.
Time frame
Baseline to weeks 1, 2, 3 of each study arm.Secondary outcomes
1
AgRP change in GH arm
Percent change in plasma AgRP level with GH therapy
Time frame
Baseline to week 1,2, 3 of study arm.2
AgRP change in liraglutide vs. placebo arms
Difference in percent change in morning fasting level of AgRP in placebo vs. liraglutide arms.
Time frame
Baseline to weeks 1,2, 3 of each study armSponsors and contacts
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Source ClinicalTrials.gov