← Trials/Trial dossier/NCT05681299

RecruitingPhase 4

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

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 25-34.9HbA1c ≤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

NCT IDNCT05681299
Org study IDAAAU4280

Timeline

Milestones

Study first posted2023-01-12actual
Study start2023-05-01actual
Last update posted2026-03-04actual
Primary completion2028-04-30estimated
Study completion2028-04-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

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 endpoints
Primary/protocol endpoint/low confidence

AgRP change in GH vs. placebo arms

Time frame:Baseline to weeks 1, 2, 3 of each study arm.

percent change from baseline, improvement

Primary/protocol endpoint/low confidence

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

Secondary/protocol endpoint/low confidence

AgRP change in GH arm

Time frame:Baseline to week 1,2, 3 of study arm.

percent change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.