Trial Outcomes & Findings for Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting (NCT NCT01388920)

NCT ID: NCT01388920

Last Updated: 2022-03-18

Results Overview

The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-03-18

Participant Flow

Participant milestones

Measure	Tesamorelin 2 mg Tesamorelin 2 mg/day for 6 months	Tesamorelin 3 mg Tesamorelin 3 mg/day for 6 months	Placebo Placebo for 6 monts
Overall Study STARTED	1	1	0
Overall Study COMPLETED	1	1	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting

Baseline characteristics by cohort

Measure	Tesamorelin 2 mg n=1 Participants Tesamorelin 2 mg/day for 6 months	Tesamorelin 3 mg n=1 Participants Tesamorelin 3 mg/day for 6 months	Placebo Placebo for 6 months	Total n=2 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 0 • n=5 Participants	51 years STANDARD_DEVIATION 0 • n=7 Participants	—	55 years STANDARD_DEVIATION 0 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	—	1 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	—	1 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	—	2 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The primary objective of the study was the change in lean body mass between baseline and Month 6. However, the study was halted approximately 1 month after patient enrollment.

The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Number and percentage of subjects with adverse events

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Frequency and severity of COPD exacerbations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Changes from baseline in fasting blood glucose

Outcome measures

Outcome data not reported

Adverse Events

Tesamorelin 2 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tesamorelin 3 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Medical Advisor

Theratechnologies

Phone: 514-336-7800

Email: jmamputu@theratech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place