← Back to Search

Hormone Therapy

Growth Hormone + Liraglutide for Metabolic Health Improvement

Phase 4
Recruiting
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 1,2, 3 of study arm.
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Study Summary

This trial will test the effects of Growth Hormone & Liraglutide on adults to measure insulin resistance, energy expenditure & body composition.

Who is the study for?
Adults aged 18-45, both healthy and those with growth hormone deficiency, can join this trial. Healthy participants should be either overweight or lean without serious medical conditions. GH deficient subjects must not have had prior GH therapy for a year and need normal thyroid and adrenal function.Check my eligibility
What is being tested?
The study tests the effects of growth hormone (GH) alone, liraglutide alone, both combined, and placebo on metabolism in adults. It's a randomized study where each participant tries all treatments in different periods with breaks in between.See study design
What are the potential side effects?
Possible side effects include changes to blood sugar levels, insulin resistance alterations, potential digestive issues from liraglutide, and reactions at injection sites for both medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am healthy, aged 18-45, and fit the gender requirement.
Select...
I am overweight or mildly obese with a high waist circumference.
Select...
I am lean with a BMI between 19 and 24.9 and do not meet the waist circumference criteria.
Select...
I am overweight/obese with no other medical conditions.
Select...
I am not taking any prescription medications or drugs.
Select...
I am one of 24 patients with a specific growth hormone deficiency.
Select...
I am between 18 and 45 years old.
Select...
I have been diagnosed with growth hormone deficiency in the last year.
Select...
I haven't taken growth hormone therapy in the last year.
Select...
My thyroid, adrenal, and reproductive hormone levels are normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 1,2, 3 of study arm.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 1,2, 3 of study arm. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AgRP change in GH vs. GH + liraglutide arms
AgRP change in GH vs. placebo arms
Secondary outcome measures
AgRP change in GH arm
AgRP change in liraglutide vs. placebo arms

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Growth hormoneActive Control1 Intervention
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.
Group II: LiraglutideActive Control1 Intervention
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.
Group III: Growth hormone and liraglutideActive Control1 Intervention
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.
Group IV: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,419 Previous Clinical Trials
2,472,342 Total Patients Enrolled

Media Library

Growth Hormone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05681299 — Phase 4
Healthy Subjects Research Study Groups: Growth hormone, Liraglutide, Growth hormone and liraglutide, Placebo
Healthy Subjects Clinical Trial 2023: Growth Hormone Highlights & Side Effects. Trial Name: NCT05681299 — Phase 4
Growth Hormone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05681299 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction Growth hormone for medicinal usage?

"Growth hormone has been approved, thus its safety rating is a 3."

Answered by AI

Is this investigation recruiting participants at the moment?

"According to information found on clinicaltrials.gov, this experiment is no longer recruiting patients as of December 27th 2022. Although the trial has ended, 804 other research projects are still seeking participants presently."

Answered by AI

Does the research protocol for this investigation permit individuals aged 45 or above to participate?

"This clinical trial is limited to 18-45 year old participants. However, there are additional trials available for both those under the age of majority as well as seniors aged 65 and up with 60 studies dedicated solely to minors and 350 specifically designed for elderly patients."

Answered by AI

Are there any eligibility requirements to join this experiment?

"This trial seeks to enrol 40 adults with growth hormone deficiency ranging between 18 and 45 years old. Of these, 20 must be overweight or obese (as classified by body mass index) with a waist circumference greater than 102cm in men and 88 cm in women (except East/South Asians whose criteria differs). The other half of participants should be leaner individuals not meeting the WC requirements. Additionally, all potential patients need to have normal blood pressure levels, hemoglobin A1C concentration below 5.7%, fasting plasma glucose concentrations under 100mg/dL, regular thyroid-stimulating hormone readings, nonhormonal contraceptive methods for premenopausal"

Answered by AI
~27 spots leftby Apr 2028