A Phase 3 interventional study of Tesamorelin and Placebo for Tesamorelin in Lipodystrophy and HIV Infections, sponsored by Theratechnologies. Completed at 47 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-30.
Sponsored by Theratechnologies · Phase 3, Interventional, and Treatment
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
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.
25 studies on the registry are indexed under HIV-Associated Lipodystrophy Syndrome; none are open to participants now.
This study's enrollment of 263 is above the median of 100 across 20 interventional studies indexed under HIV-Associated Lipodystrophy Syndrome.
Browse HIV-Associated Lipodystrophy Syndrome studies →Theratechnologies is the lead sponsor of 10 studies on the registry; none are open to participants now.
Compared within HIV-Associated Lipodystrophy Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lipodystrophy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tesamorelin 2 mg/day for 12 months
Drug: Tesamorelin
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Drug: Tesamorelin · Drug: Placebo for Tesamorelin
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Drug: Tesamorelin · Drug: Placebo for Tesamorelin
Also known as: Egrifta
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.
Time frame: 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.
Time frame: Baseline and Week 52
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.
Time frame: Baseline and Week 52
Changes From Baseline in Triglycerides at Week 52
Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.
Time frame: Baseline and Week 52
Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52
Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported.
Time frame: Baseline and Week 52
| Milestone | Tesamorelin (52 Weeks) | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo-Tesamorelin (P-T) |
|---|---|---|---|
| Started | 92 | 85 | 86 |
| Completed | 80 | 63 | 72 |
| Not completed | 12 | 22 | 14 |
| Withdrew: Withdrawal by subject | 8 | 10 | 7 |
| Withdrew: Adverse event | 1 | 4 | 5 |
| Withdrew: Lost to follow-up | 2 | 2 | 1 |
| Withdrew: Protocol violation | 1 | 3 | 1 |
| Withdrew: Unknown reason | 0 | 3 | 0 |
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.
| cm^2 | Tesamorelin 52 Weeks | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) |
|---|---|---|---|
| Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 | -41 ± 57 | 0 ± 53 | -26 ± 47 |
Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.
| mg/dL | Tesamorelin (52 Weeks) | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) |
|---|---|---|---|
| Changes From Baseline in Triglycerides at Week 52 | -37 ± 196 | 4 ± 177 | 1 ± 120 |
Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported.
| ratio | Tesamorelin 52 Weeks | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) |
|---|---|---|---|
| Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 | -0.23 ± 1.75 | 0.13 ± 1.19 | 0.06 ± 1.01 |
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
| mg/dL | Tesamorelin 52 Weeks | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) |
|---|---|---|---|
| Changes From Baseline in Fasting Blood Glucose at Week 52 | 0 ± 16 | -2 ± 34 | 1 ± 21 |
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.
| mg/dL | Tesamorelin 52 Weeks | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) |
|---|---|---|---|
| Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 | -2 ± 38 | 2 ± 35 | 7 ± 37 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tesamorelin 52 Weeks | — | 3/92 (3.3%) | 17/92 (18.5%) |
| Tesamorelin (26 Weeks) - Placebo (26 Weeks) | — | 1/85 (1.2%) | 11/85 (12.9%) |
| Placebo (26 Weeks) - Tesamorelin (26 Weeks) | — | 3/86 (3.5%) | 28/86 (32.6%) |
| Event | Tesamorelin 52 Weeks | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 0/92 | 1/85 | 0/86 |
| Hodgkin diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/92 | 0/85 | 1/86 |
| NephrolithiasisRenal and urinary disorders | 0/92 | 0/85 | 1/86 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/92 | 0/85 | 1/86 |
| RetinopathyEye disorders | 1/92 | 0/85 | 0/86 |
| Chest painGeneral disorders | 1/92 | 0/85 | 0/86 |
| Mental status changesPsychiatric disorders | 1/92 | 0/85 | 0/86 |
| Event | Tesamorelin 52 Weeks | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) |
|---|---|---|---|
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 8/92 | 4/85 | 3/86 |
| DiarrhoeaGastrointestinal disorders | 3/92 | 4/85 | 5/86 |
| Injection site erythemaGeneral disorders | 3/92 | 0/85 | 5/86 |
| Injection site painGeneral disorders | 0/92 | 0/85 | 5/86 |
| Musculosketal stiffnessMusculoskeletal and connective tissue disorders | 1/92 | 0/85 | 5/86 |
| ParesthesiaNervous system disorders | 2/92 | 3/85 | 5/86 |
| InsomniaPsychiatric disorders | 0/92 | 0/85 | 5/86 |
| Age, Continuous(years) | Tesamorelin 52 Weeks | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | Total |
|---|---|---|---|---|
| Mean | 47.7 ± 6.9 | 48.9 ± 7.2 | 48.4 ± 7.9 | 48.3 ± 7.3 |
| Sex: Female, Male(Participants) | Tesamorelin 52 Weeks | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | Total |
|---|---|---|---|---|
| Female | 9 | 9 | 11 | 29 |
| Male | 83 | 76 | 75 | 234 |
Plan to share: No
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Studies of the drug tested here: Tesamorelin
HIV-Associated Lipodystrophy Syndrome →
Theratechnologies