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

Be between 18 and 65 years old

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

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 1,2, 3 of study arm.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AgRP change in GH vs. GH + liraglutide arms

AgRP change in GH vs. placebo arms

Secondary study objectives

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 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 II: 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 III: 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 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.

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