Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 387
- Locations
- 26
- Primary Endpoint
- Percent change in total fat mass
Study Overview
Brief Summary
This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.
Detailed Description
Dose regimen of growth hormone based on weight: Starting dose was 4.0 micrograms/kg/day for four months, then increased to 8 micrograms/kg/day for two months, and then increased to 12 micrograms/kg/day for a further two months (eight months in total).
Dose regimen of growth hormone based on individual patient needs: Starting dose was 200 micrograms/day, then increased by 200 micrograms/day every two months for an additional six months (eight months in total) as needed for optimal treatment results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have growth hormone deficiency that started in childhood or adulthood
- •Have not received any growth hormone treatment in the last 12 months
- •Have had a growth hormone stimulation test within the last two years showing abnormally low response
- •Have received adequate and stable hormonal replacement for other hormone deficiencies during the last three months
Exclusion Criteria
- •Presence of clinically significant diseases, such as cancer, lung, heart, liver, kidney, neuromuscular, genetic, or severe psychiatric diseases
- •Recent growth of pituitary tumor or other intracranial tumor
- •History of acromegaly
- •Taking medication to suppress appetite or reduce weight, or antidepressant drugs
- •Poorly-controlled high blood pressure or diabetes
Outcomes
Primary Outcomes
Percent change in total fat mass
Time Frame: Eight months
Secondary Outcomes
- Safety(Eight months)