Trial Outcomes & Findings for TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy (NCT NCT00608023)
NCT ID: NCT00608023
Last Updated: 2022-09-30
Results Overview
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
263 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2022-09-30
Participant Flow
Participant milestones
| Measure |
Tesamorelin (52 Weeks)
Tesamorelin 2 mg/day for 52 Weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo-Tesamorelin (P-T)
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
85
|
86
|
|
Overall Study
COMPLETED
|
80
|
63
|
72
|
|
Overall Study
NOT COMPLETED
|
12
|
22
|
14
|
Reasons for withdrawal
| Measure |
Tesamorelin (52 Weeks)
Tesamorelin 2 mg/day for 52 Weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo-Tesamorelin (P-T)
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
10
|
7
|
|
Overall Study
Adverse Event
|
1
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
3
|
1
|
|
Overall Study
Unknown reason
|
0
|
3
|
0
|
Baseline Characteristics
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Baseline characteristics by cohort
| Measure |
Tesamorelin 52 Weeks
n=92 Participants
Tesamorelin 2 mg/day for 52 weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
n=85 Participants
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
n=86 Participants
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
234 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Outcome measures
| Measure |
Tesamorelin 52 Weeks
n=92 Participants
Tesamorelin 2 mg/day for 52 weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
n=85 Participants
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
n=86 Participants
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Changes From Baseline in Fasting Blood Glucose at Week 52
|
0 mg/dL
Standard Deviation 16
|
-2 mg/dL
Standard Deviation 34
|
1 mg/dL
Standard Deviation 21
|
PRIMARY outcome
Timeframe: Baseline and Week 52Glucose 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.
Outcome measures
| Measure |
Tesamorelin 52 Weeks
n=92 Participants
Tesamorelin 2 mg/day for 52 weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
n=85 Participants
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
n=86 Participants
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
|
-2 mg/dL
Standard Deviation 38
|
2 mg/dL
Standard Deviation 35
|
7 mg/dL
Standard Deviation 37
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: All data were included in the analysis by intention to treat principles. Intent to treat populations were defined as all randomized subjects who were exposed to study drug (i.e injection of at least 1 dose of study drug).
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.
Outcome measures
| Measure |
Tesamorelin 52 Weeks
n=92 Participants
Tesamorelin 2 mg/day for 52 weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
n=85 Participants
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
n=86 Participants
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
|
-41 cm^2
Standard Deviation 57
|
0 cm^2
Standard Deviation 53
|
-26 cm^2
Standard Deviation 47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.
Outcome measures
| Measure |
Tesamorelin 52 Weeks
n=92 Participants
Tesamorelin 2 mg/day for 52 weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
n=85 Participants
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
n=86 Participants
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Changes From Baseline in Triglycerides at Week 52
|
-37 mg/dL
Standard Deviation 196
|
4 mg/dL
Standard Deviation 177
|
1 mg/dL
Standard Deviation 120
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Blood 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.
Outcome measures
| Measure |
Tesamorelin 52 Weeks
n=92 Participants
Tesamorelin 2 mg/day for 52 weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
n=85 Participants
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
n=86 Participants
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52
|
-0.23 ratio
Standard Deviation 1.75
|
0.13 ratio
Standard Deviation 1.19
|
0.06 ratio
Standard Deviation 1.01
|
Adverse Events
Tesamorelin 52 Weeks
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tesamorelin 52 Weeks
n=92 participants at risk
Tesamorelin 2 mg/day for 52 weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
n=85 participants at risk
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
n=86 participants at risk
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Eye disorders
Retinopathy
|
1.1%
1/92
|
0.00%
0/85
|
0.00%
0/86
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/92
|
1.2%
1/85
|
0.00%
0/86
|
|
General disorders
Chest pain
|
1.1%
1/92
|
0.00%
0/85
|
0.00%
0/86
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin disease
|
0.00%
0/92
|
0.00%
0/85
|
1.2%
1/86
|
|
Psychiatric disorders
Mental status changes
|
1.1%
1/92
|
0.00%
0/85
|
0.00%
0/86
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/92
|
0.00%
0/85
|
1.2%
1/86
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/92
|
0.00%
0/85
|
1.2%
1/86
|
Other adverse events
| Measure |
Tesamorelin 52 Weeks
n=92 participants at risk
Tesamorelin 2 mg/day for 52 weeks
|
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
n=85 participants at risk
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
|
Placebo (26 Weeks) - Tesamorelin (26 Weeks)
n=86 participants at risk
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
3/92
|
4.7%
4/85
|
5.8%
5/86
|
|
General disorders
Injection site erythema
|
3.3%
3/92
|
0.00%
0/85
|
5.8%
5/86
|
|
General disorders
Injection site pain
|
0.00%
0/92
|
0.00%
0/85
|
5.8%
5/86
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
8.7%
8/92
|
4.7%
4/85
|
3.5%
3/86
|
|
Musculoskeletal and connective tissue disorders
Musculosketal stiffness
|
1.1%
1/92
|
0.00%
0/85
|
5.8%
5/86
|
|
Nervous system disorders
Paresthesia
|
2.2%
2/92
|
3.5%
3/85
|
5.8%
5/86
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/92
|
0.00%
0/85
|
5.8%
5/86
|
Additional Information
Marilyn de Chantal, Global Senior Medical Director
Theratechnologies
Phone: 1 438-315-6624
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60