Effects of GH and Lirglutide on AgRP

NCTNCT05681299Other idAAAU4280

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Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 40 participants (estimated)
Sponsor: Columbia University · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 1 May 2023
Primary completion: 30 Apr 2028 (estimated)
Completion: 30 Apr 2028 (estimated)
First posted: 12 Jan 2023
Last update posted: 4 Mar 2026
Conditions: Healthy · Growth Hormone Deficiency

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026202720282029

Ph 4
Effects of GH and Lirglutide on AgRP
NCT05681299
1 May 2023 to est. 30 Apr 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

growth hormone and lirglutideDrug
growth hormoneDrug
liraglutideDrug
PlaceboDrug

Arms4

Active comparator
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. Injections will be performed from the night of day 0 to the night of day 20.
Active comparator
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. Injections will be performed from the night of day 0 to the night of day 20.
Active comparator
Growth hormone and liraglutide
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. 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. Injections will be performed from the night of day 0 to the night of day 20.
Placebo comparator
Placebo
Placebo will be administered as one nightly subcutaneous self-injection at 9-11pm from the night of day 0 to the night of day 20.

Primary outcomes2

Outcomes the sponsor listed as primary.

AgRP change in GH vs. placebo arms
Time frame · Baseline to weeks 1, 2, 3 of each study arm.
Registry description
Difference in percent change in morning fasting level of AgRP (agouti-related peptide) in plasma in GH vs. placebo arms.
AgRP change in GH vs. GH + liraglutide arms
Time frame · Baseline to weeks 1, 2, 3 of each study arm.
Registry description
Difference in percent change in morning fasting level of AgRP in plasma in GH vs. GH+liraglutide arms.

Secondary outcomes(2)

AgRP change in GH arm
Time frame · Baseline to week 1,2, 3 of study arm.
Registry description
Percent change in plasma AgRP level with GH therapy
AgRP change in liraglutide vs. placebo arms
Time frame · Baseline to weeks 1,2, 3 of each study arm
Registry description
Difference in percent change in morning fasting level of AgRP in placebo vs. liraglutide arms.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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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