Trial Outcomes & Findings for Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk (NCT NCT03375788)
NCT ID: NCT03375788
Last Updated: 2025-11-20
Results Overview
Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy. All available data used; data not available for 1 participant in tesamorelin group and 3 participants in placebo group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
change from baseline to 12 months
Results posted on
2025-11-20
Participant Flow
Participant milestones
| Measure |
Tesamorelin
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Placebo
identical placebo given subcutaneously daily
Identical Placebo: Placebo injection daily
|
|---|---|---|
|
12-month Double-blind Phase
STARTED
|
26
|
25
|
|
12-month Double-blind Phase
COMPLETED
|
19
|
19
|
|
12-month Double-blind Phase
NOT COMPLETED
|
7
|
6
|
|
6 Month Open Label Phase
STARTED
|
17
|
13
|
|
6 Month Open Label Phase
COMPLETED
|
16
|
12
|
|
6 Month Open Label Phase
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
Baseline characteristics by cohort
| Measure |
Tesamorelin
n=26 Participants
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Placebo
n=25 Participants
identical placebo given subcutaneously daily
Identical Placebo: Placebo injection daily
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 10
|
47 years
STANDARD_DEVIATION 11 • n=4 Participants
|
47 years
STANDARD_DEVIATION 11 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
|
15 Participants
n=4 Participants
|
38 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic ethnicity
|
1 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
26 participants
|
25 participants
n=4 Participants
|
51 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: change from baseline to 12 monthsLiver Fat Content as measured by hydrogen-magnetic resonance spectroscopy. All available data used; data not available for 1 participant in tesamorelin group and 3 participants in placebo group.
Outcome measures
| Measure |
Tesamorelin
n=18 Participants
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Placebo
n=16 Participants
identical placebo given subcutaneously daily
Identical Placebo: Placebo injection daily
|
|---|---|---|
|
Liver Fat Content
|
-5.3 percent change in hepatic fat fraction
Interval -13.0 to -1.4
|
3.6 percent change in hepatic fat fraction
Interval -6.2 to 7.9
|
SECONDARY outcome
Timeframe: change from baseline to 12 monthsNonalcoholic Fatty Liver Disease Activity Score (NAS, scored between 0-8, with higher indicating more severe disease) from liver biopsy. All available data used; data not available for 3 participants in placebo group and 1 participant in tesamorelin group.
Outcome measures
| Measure |
Tesamorelin
n=18 Participants
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Placebo
n=16 Participants
identical placebo given subcutaneously daily
Identical Placebo: Placebo injection daily
|
|---|---|---|
|
NAFLD Activity Score
|
0 units on a scale
Interval -2.0 to 0.0
|
0 units on a scale
Interval -1.0 to 1.0
|
SECONDARY outcome
Timeframe: change from baseline to 12 monthsAll available data utilized. Data not available for 2 participants in tesamorelin group and 3 participants in placebo group.
Outcome measures
| Measure |
Tesamorelin
n=17 Participants
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Placebo
n=16 Participants
identical placebo given subcutaneously daily
Identical Placebo: Placebo injection daily
|
|---|---|---|
|
Low Density Lipoprotein (LDL) Cholesterol
|
-5.7 milligrams per deciliter
Standard Deviation 27
|
-0.7 milligrams per deciliter
Standard Deviation 16
|
SECONDARY outcome
Timeframe: change from baseline to 12 monthsAll available data utilized. Data not available for 2 participants in placebo group.
Outcome measures
| Measure |
Tesamorelin
n=19 Participants
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Placebo
n=17 Participants
identical placebo given subcutaneously daily
Identical Placebo: Placebo injection daily
|
|---|---|---|
|
C-reactive Protein
|
-0.9 milligrams per liter (mg/L)
Standard Deviation 4.2
|
0.0 milligrams per liter (mg/L)
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: change from baseline to 12 monthsfibrosis score from liver biopsy; all available data used - data not available for 1 participant in tesamorelin group and 3 participants in placebo group. Fibrosis stage scored from 0-4, where 0 indicates no fibrosis and 4 indicates most severe fibrosis, which is cirrhosis.
Outcome measures
| Measure |
Tesamorelin
n=18 Participants
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Placebo
n=16 Participants
identical placebo given subcutaneously daily
Identical Placebo: Placebo injection daily
|
|---|---|---|
|
Fibrosis Score
|
0 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.5
|
Adverse Events
Double-blind Phase: Tesamorelin
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Double-blind Phase: Placebo
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Open Label Phase
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind Phase: Tesamorelin
n=26 participants at risk
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously for first 12 months
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Double-blind Phase: Placebo
n=25 participants at risk
identical placebo given subcutaneously daily for first 12 months
Identical Placebo: Placebo injection daily
|
Open Label Phase
n=30 participants at risk
all patients receiving open-label tesamorelin from months 12-18
|
|---|---|---|---|
|
Surgical and medical procedures
rotator cuff surgery
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Gastrointestinal disorders
appendicitis
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Psychiatric disorders
major depressive disorder
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Surgical and medical procedures
elective knee replacement
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Injury, poisoning and procedural complications
liver hematoma following biopsy
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
Other adverse events
| Measure |
Double-blind Phase: Tesamorelin
n=26 participants at risk
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously for first 12 months
Tesamorelin: Tesamorelin F4 formulation 1.4mg daily
|
Double-blind Phase: Placebo
n=25 participants at risk
identical placebo given subcutaneously daily for first 12 months
Identical Placebo: Placebo injection daily
|
Open Label Phase
n=30 participants at risk
all patients receiving open-label tesamorelin from months 12-18
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
3.3%
1/30 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
3.3%
1/30 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
6/26 • Number of events 10 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
6.7%
2/30 • Number of events 3 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Syndrome
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 2 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Nervous system disorders
Concussion
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Edema
|
23.1%
6/26 • Number of events 9 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
3.3%
1/30 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Hepatobiliary disorders
elevated gamma glutamyl transferase
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Musculoskeletal and connective tissue disorders
Fall
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Infections and infestations
fever
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Endocrine disorders
Galactorrhea
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Gastrointestinal disorders
Gastrointeritis
|
7.7%
2/26 • Number of events 3 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 2 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
12.0%
3/25 • Number of events 3 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Endocrine disorders
Hyperglycemia
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
3.3%
1/30 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Injection site bruising
|
15.4%
4/26 • Number of events 5 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
19.2%
5/26 • Number of events 9 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
10.0%
3/30 • Number of events 3 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Injection site itching
|
7.7%
2/26 • Number of events 2 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Injection site redness
|
7.7%
2/26 • Number of events 2 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Injection site stinging
|
30.8%
8/26 • Number of events 12 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 3 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
30.0%
9/30 • Number of events 10 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
11.5%
3/26 • Number of events 3 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Gastrointestinal disorders
Loose stool
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Nervous system disorders
Mild loss of coordination
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Renal and urinary disorders
Nocturia
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Infections and infestations
Infection (unspecified)
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
3.3%
1/30 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Injection site complaints, other
|
19.2%
5/26 • Number of events 5 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
8.0%
2/25 • Number of events 2 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
20.0%
6/30 • Number of events 6 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Injury, poisoning and procedural complications
Pain following liver biopsy
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Endocrine disorders
Hyperparathyroidism
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
2/26 • Number of events 2 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
3.3%
1/30 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Renal and urinary disorders
renal cyst
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Musculoskeletal and connective tissue disorders
Vertebral fractures (from fall)
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
4.0%
1/25 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Blood and lymphatic system disorders
Lower extremity venous thrombosis
|
3.8%
1/26 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/30 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Surgical and medical procedures
Wisdom teeth extraction
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
3.3%
1/30 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/26 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
0.00%
0/25 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
3.3%
1/30 • Number of events 1 • Adverse events for the double-blind phase occurred during months 0-12 of the study (12-month double-blind phase). Adverse events for the open-label phase occurred during months 12-18 of the study (6-month open label phase that occurred at the end of the 12- month double-blind phase).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place