A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Theratechnologies
- Enrollment
- 263
- Locations
- 47
- Primary Endpoint
- Changes From Baseline in Fasting Blood Glucose at Week 52
Study Overview
Brief Summary
Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
Detailed Description
HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
- •Signed informed consent before any trial-related activities.
Exclusion Criteria
- •Fasting blood glucose >8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Arms & Interventions
Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
Intervention: Tesamorelin (Drug)
Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Intervention: Tesamorelin (Drug)
Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Intervention: Placebo for Tesamorelin (Drug)
Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Intervention: Tesamorelin (Drug)
Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Intervention: Placebo for Tesamorelin (Drug)
Outcomes
Primary Outcomes
Changes From Baseline in Fasting Blood Glucose at Week 52
Time Frame: Baseline and Week 52
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
Time Frame: Baseline and Week 52
Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.
Secondary Outcomes
- Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52(Baseline and Week 52)