LipodystrophyPhase 3NCT00608023
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
A Phase 3 study testing Tesamorelin in people with Lipodystrophy and HIV Infections, run by Theratechnologies at 47 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lipodystrophy, HIV Infections
- What is being tested?
- Tesamorelin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 47 sitesin 6 countries
- Study dates
- Aug 2007to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
- Signed informed consent before any trial-related activities.
Who cannot join
- Fasting blood glucose >8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
United States27 sites
AIDS Research Consortium Atlanta (ARCA)
Atlanta, Georgia, 30308
Central Texas Clinical Research
Austin, Texas, 78705
University of Alabama at Birmingham
Birmingham, Alabama, 35294-2170
Tufts University School of Medicine
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7215
Northern Healthcare
Chicago, Illinois, 60657
Northstar Medical
Chicago, Illinois, 60657
University Hospitals of Cleveland
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75232
Denver Public Health Department
Denver, Colorado, 80204-4507
Office of Dr. Gary Richmond
Fort Lauderdale, Florida, 33316
ID Associates
Hillsborough, New Jersey, 08844
Indiana University Department of Medicine
Indianapolis, Indiana, 46202
Somero, Michael
Indio, California, 92201
Hendry/Glades County Health Departments
LaBelle, Florida, 33935
UCLA School of Medicine
Los Angeles, California, 90035
AIDS Community Research Initiative of America
New York, New York, 10018
Office of Dr. Michael Somero
Palm Springs, California, 92262
Body Positive Inc.
Phoenix, Arizona, 85006
University of California
San Francisco, California, 94110
Kaiser Permanente
San Francisco, California, 94118
UCSF/VA Medical Center
San Francisco, California, 94121
Swedish Medical Center
Seattle, Washington, 98104
The Research Institute
Springfield, Massachusetts, 01107
Infectious Disease Research Institute Inc.
Tampa, Florida, 33614
AIDS Research Alliance
West Hollywood, California, 90069
Canada7 sites
Centre Hospitalier Universitaire de Santé de l'Estrie
Fleurimont, Quebec, J1H 5N4
McMaster University Health Sciences Centre
Hamilton, Ontario, L8N 3Z5
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Groupe de Recherche en Rhumatologie et maladies osseuses
Ste-Foy, Quebec, G1V 3M7
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St-Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
United Kingdom5 sites
BSUH NHS Trust
Brighton, BN2 1ES
St Georges Hospital
London, 17 0QT
Royal Free Hospital
London, NW3 2QG
Chelsea and Westminster Hospital
London, SW10 9TH
St Mary's NHS Trust
London, W2 1NY
France4 sites
Hôpital Hotel Dieu Lyon
Lyon, 69288
Hotel Dieu
Nantes, 44093
Hopital Europeen Georges Pompidou
Paris, 75015
Hopital Necker
Paris, 75743
Spain3 sites
Hosp. Ramon y Cajal
Madrid, 28034
Hosp. Clinico San Carlos
Madrid, 28040
Hosp.C.U.de Santiago
Santiago de Compostela, 15706
About this study
Official title: 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
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
Read the 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.
- Conditions
- Lipodystrophy, HIV Infections
- Being tested
- Tesamorelin, Placebo for Tesamorelin
- Keywords
- HIV, Lipodystrophy, Abdominal fat accumulation, Growth hormone releasing hormone, HIV-associated lipodystrophy, Treatment experienced
- Medical subject headings
- Lipodystrophy, HIV Infections, HIV-Associated Lipodystrophy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesamorelinDrug
Also called Egrifta
Placebo for TesamorelinDrug
| Study group | Role | What they receive |
|---|---|---|
| Tesamorelin 12 months (T-T) | Experimental | Tesamorelin 2 mg/day for 12 months Receives: Drug: Tesamorelin |
| Tesamorelin-Placebo (T-P) | Experimental | Tesamorelin 2 mg/day for 6 months - Placebo for 6 months Receives: Drug: Tesamorelin; Drug: Placebo for Tesamorelin |
| Placebo-Tesamorelin (P-T) | Experimental | Placebo 6 months - Tesamorelin 2 mg/day for 6 months Receives: Drug: Tesamorelin; Drug: Placebo for Tesamorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline in Fasting Blood Glucose at Week 52
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Measured: Baseline and Week 52
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at 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.
Measured: Baseline and Week 52
Secondary outcomes (1)
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theratechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Grinspoon, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608023
- Sponsor's protocol ID
- TH9507-CTR-1012
- Status last verified
- Sep 2022
- First submitted
- 23 Jan 2008
- Last updated
- 30 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614.
PubMed 28832410Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. doi: 10.1093/cid/cis251. Epub 2012 Apr 10.
PubMed 22495074Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. doi: 10.1210/jc.2010-0490. Epub 2010 Jun 16.
PubMed 20554713Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff.
PubMed 20101189
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00608023
- Acronym / sponsor ID
- TH9507-CTR-1012
- Conditions
- Lipodystrophy, HIV Infections
- Keywords
- HIV, Lipodystrophy, Abdominal fat accumulation, Growth hormone releasing hormone, HIV-associated lipodystrophy, Treatment experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- TheratechnologiesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 15 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tesamorelin 12 months (T-T) | Experimental | Drug: TesamorelinTesamorelin 2 mg/day for 12 months |
| Tesamorelin-Placebo (T-P) | Experimental | Drug: Tesamorelin, Drug: Placebo for TesamorelinTesamorelin 2 mg/day for 6 months - Placebo for 6 months |
| Placebo-Tesamorelin (P-T) | Experimental | Drug: Tesamorelin, Drug: Placebo for TesamorelinPlacebo 6 months - Tesamorelin 2 mg/day for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
- Signed informed consent before any trial-related activities.
Key exclusion criteria (1 listed)
- Fasting blood glucose >8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TesamorelinAlso: Egrifta | Drug | Placebo-Tesamorelin (P-T), Tesamorelin 12 months (T-T), Tesamorelin-Placebo (T-P) |
| Placebo for Tesamorelin | Drug | Placebo-Tesamorelin (P-T), Tesamorelin-Placebo (T-P) |
Primary outcome
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.
1 secondary outcome
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Time frame: Baseline and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28832410Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614.
- Derived from this study: PubMed 22495074Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. doi: 10.1093/cid/cis251. Epub 2012 Apr 10.
- Derived from this study: PubMed 20554713Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. doi: 10.1210/jc.2010-0490. Epub 2010 Jun 16.
- Derived from this study: PubMed 20101189Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Grinspoon, MD principal investigator
Massachusetts General Hospital
47 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tesamorelin in people with Lipodystrophy and HIV Infections, run by Theratechnologies at 47 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Canada, United Kingdom, France, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline in Fasting Blood Glucose at Week 52 (time frame: Baseline and Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00608023, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022; AzTrials last refreshed its copy on 1 Nov 2026.