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Effects of GH and Lirglutide on AgRP
Effects of Administration of Growth Hormone, Without and With Liraglutide, on AgRP, Energy and Glucose Metabolism in Healthy and GH Deficient Humans
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
40
estimated
Study population
Healthy volunteers, Obesity / overweight
Key I/E criteria
•BMI 25-34.9•HbA1c ≤5.7%•Healthy volunteers
Primary endpoint
•AgRP change in GH
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Other (unclassified)
4 endpointsAgRP change in GH vs. placebo arms
Time frame:Baseline to weeks 1, 2, 3 of each study arm.
percent change from baseline, improvement
AgRP change in GH vs. GH + liraglutide arms
Time frame:Baseline to weeks 1, 2, 3 of each study arm.
percent change from baseline, improvement
AgRP change in GH arm
Time frame:Baseline to week 1,2, 3 of study arm.
percent change from baseline, descriptive
AgRP change in liraglutide vs. placebo arms
Time frame:Baseline to weeks 1,2, 3 of each study arm
percent change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.