CompletedPhase 3

TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

United States263 participantsStarted 2007-08

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Changes From Baseline in Fasting Blood Glucose at Week 52

Timeframe: Baseline and Week 52

Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52

Timeframe: Baseline and Week 52

Trial details

NCT IDNCT00608023

SponsorTheratechnologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-10

Results submitted2013-11-27

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