Effects of GH and Lirglutide on AgRP

NCT05681299 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: AAAU4280
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Growth Hormone Deficiency

Keywords

growth hormone; liraglutide; AgRP

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (2)

• AgRP change in GH arm

  Baseline to week 1,2, 3 of study arm.

• AgRP change in liraglutide vs. placebo arms

  Baseline to weeks 1,2, 3 of each study arm

Study Arms (4)

Growth hormone

ACTIVE COMPARATOR

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.

Drug: growth hormone

Liraglutide

ACTIVE COMPARATOR

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.

Drug: liraglutide

Growth hormone and liraglutide

ACTIVE COMPARATOR

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.

Drug: growth hormone and lirglutide

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

growth hormone and lirglutide DRUG

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 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 and liraglutide

liraglutide DRUG

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.

Liraglutide

growth hormone DRUG

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.

Growth hormone

Placebo DRUG

Placebo will be taken by nightly subcutaneous injection at 9-11 pm.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HEALTHY SUBJECTS
• 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
• GH DEFICIENT SUBJECTS
• patients with isolated GH deficiency:12 males, 12 females.
• Ages 18-45 years
• Diagnosis of isolated GH deficiency based on accepted, BMI-appropriate GH stimulation test cut offs within 12 months of enrollment
• No prior GH therapy within 12 months of study enrollment
• Normal thyroid, adrenal and gonadal function documented by accepted stimulation test and clinical criteria
• Premenopausal women: use of nonhormonal method of contraception

You may not qualify if:

• HEALTHY SUBJECTS
• 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
• GH DEFICIENT SUBJECTS
• DM requiring medication
• HbA1C \> 7.5
• Malignancy, pancreatitis or thyroid cancer history.
• Deficiency of other pituitary hormones, liver or renal disease
• Use of glucocorticoids, hormonal supplements or medications that could affect GH or IGF-1 or for weight loss within 6 months of enrollment
• \. Recent dieting, weight change \> 5%, pregnancy, lactation or heavy exercise 6. Current smoking

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Neuroendocrine Unit and Pituitary Center, Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone; Liraglutide

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones

Central Study Contacts

Pamela Freda, MD

CONTACT

2123052254; puf1@cumc.columbia.edu

Rosa Lazarte

CONTACT

2123054921; rl2345@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine at CUIMC

Model Details: Participant blind

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 12, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)