Phase 3
N=263
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Lipodystrophy · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00608023 ↗Enrolled (actual)
263
Serious AEs
2.7%
Results posted
Jan 2014
Primary outcome: Primary: Changes From Baseline in Fasting Blood Glucose at Week 52 — 0; -2; 1 mg/dL — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tesamorelin (Drug); Placebo for Tesamorelin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theratechnologies
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline in Fasting Blood Glucose at Week 52 |
0; -2; 1 | >0.05 |
| PRIMARY Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 |
-2; 2; 7 | >0.05 |
| SECONDARY Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 |
-41; 0; -26 | <0.001 sig |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00608023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.