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NCT00123253 · ClinicalTrials.gov registry record · Phase 3
TH9507 in Patients With HIV-Associated Lipodystrophy
A Phase 3 study, sponsored by Theratechnologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
NCT00123253: Completed Phase 3 study, sponsored by Theratechnologies.
NCT00123253 is a Phase 3 study that has completed, run by Theratechnologies. The registered enrollment target is 412 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00123253, a Phase 3 study, has completed, sponsored by Theratechnologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
Study Summary
HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation.
Interventions
- DRUG TH9507
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
What the finished NCT00123253 record still lists
NCT00123253 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which TH9507 is the first listed.
NCT00123253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00123253 about?
NCT00123253 is a clinical study titled "TH9507 in Patients With HIV-Associated Lipodystrophy". HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous rand...
What is the current status of trial NCT00123253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2005-06. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00123253?
The interventions under investigation include: TH9507 (DRUG).
Who is sponsoring clinical trial NCT00123253?
This trial is sponsored by Theratechnologies, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00123253's enrollment target sits among peer trials
412 906th of 2000 higher than 1,092 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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