Trial Outcomes & Findings for A Study in Older Participants Who Have Fallen and Have Muscle Weakness (NCT NCT01604408)
NCT ID: NCT01604408
Last Updated: 2018-04-25
Results Overview
Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
Baseline to 24 weeks
Results posted on
2018-04-25
Participant Flow
Participant milestones
| Measure |
LY2495655
Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.
|
Placebo
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
102
|
99
|
|
Treatment Period 1
Received at Least 1 Dose of Study Drug
|
102
|
99
|
|
Treatment Period 1
COMPLETED
|
102
|
98
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 2
STARTED
|
102
|
98
|
|
Treatment Period 2
COMPLETED
|
100
|
96
|
|
Treatment Period 2
NOT COMPLETED
|
2
|
2
|
|
Treatment Period 3
STARTED
|
100
|
96
|
|
Treatment Period 3
COMPLETED
|
95
|
91
|
|
Treatment Period 3
NOT COMPLETED
|
5
|
5
|
|
Treatment Period 4
STARTED
|
95
|
91
|
|
Treatment Period 4
COMPLETED
|
92
|
89
|
|
Treatment Period 4
NOT COMPLETED
|
3
|
2
|
|
Treatment Period 5
STARTED
|
92
|
89
|
|
Treatment Period 5
COMPLETED
|
88
|
89
|
|
Treatment Period 5
NOT COMPLETED
|
4
|
0
|
|
Treatment Period 6
STARTED
|
88
|
89
|
|
Treatment Period 6
COMPLETED
|
86
|
87
|
|
Treatment Period 6
NOT COMPLETED
|
2
|
2
|
|
Observation Period
STARTED
|
86
|
87
|
|
Observation Period
COMPLETED
|
85
|
84
|
|
Observation Period
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
LY2495655
Participants received a 315-milligram (mg) dose of LY2495655, administered subcutaneously (SC), every 4 weeks (Q4W) for 20 weeks.
|
Placebo
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
|---|---|---|
|
Treatment Period 1
Protocol Violation
|
0
|
1
|
|
Treatment Period 2
Withdrawal by Subject
|
1
|
1
|
|
Treatment Period 2
Protocol Violation
|
1
|
0
|
|
Treatment Period 2
Adverse Event
|
0
|
1
|
|
Treatment Period 3
Protocol Violation
|
1
|
1
|
|
Treatment Period 3
Adverse Event
|
0
|
3
|
|
Treatment Period 3
Withdrawal by Subject
|
3
|
1
|
|
Treatment Period 3
Sponsor Decision
|
1
|
0
|
|
Treatment Period 4
Death
|
1
|
0
|
|
Treatment Period 4
Withdrawal by Subject
|
2
|
1
|
|
Treatment Period 4
Adverse Event
|
0
|
1
|
|
Treatment Period 5
Adverse Event
|
4
|
0
|
|
Treatment Period 6
Lost to Follow-up
|
0
|
1
|
|
Treatment Period 6
Adverse Event
|
2
|
0
|
|
Treatment Period 6
Sponsor decision
|
0
|
1
|
|
Observation Period
Adverse Event
|
1
|
1
|
|
Observation Period
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study in Older Participants Who Have Fallen and Have Muscle Weakness
Baseline characteristics by cohort
| Measure |
LY2495655
n=102 Participants
Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
|
Placebo
n=99 Participants
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.84 years
STANDARD_DEVIATION 4.73 • n=5 Participants
|
82.57 years
STANDARD_DEVIATION 5.20 • n=7 Participants
|
82.20 years
STANDARD_DEVIATION 4.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: All participants who received at least 1 dose of LY2495655 or placebo with evaluable aLBM data.
Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.
Outcome measures
| Measure |
LY2495655
n=77 Participants
Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
|
Placebo
n=82 Participants
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
|---|---|---|
|
Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)
|
0.303 kilograms (kg)
Standard Error 0.085
|
-0.123 kilograms (kg)
Standard Error 0.083
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: All participants who received at least 1 dose of LY2495655 or placebo with evaluable StC time data.
Change from baseline to the 24-week endpoint in StC time is presented. StC time was assessed by measuring the fastest time achieved to climb 4 steps on a 4-step staircase (the test was performed 2 times). LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline StC score as covariate.
Outcome measures
| Measure |
LY2495655
n=80 Participants
Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
|
Placebo
n=84 Participants
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
|---|---|---|
|
Change From Baseline in Stair Climbing (StC) Time
|
-0.276 seconds
Standard Error 0.182
|
0.184 seconds
Standard Error 0.178
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: All participants who received at least 1 dose of LY2495655 or placebo with evaluable RCS time data.
Change from baseline to 24-week endpoint in RCS time is presented. In the RCS test, participants were asked to rise from a chair 5 times as fast as possible with their arms folded on their chest. Performance was measured in seconds, as the time from the initial seated position to the final standing position. LS means were calculated using an MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline RCS time as covariate.
Outcome measures
| Measure |
LY2495655
n=53 Participants
Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
|
Placebo
n=64 Participants
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
|---|---|---|
|
Change From Baseline in Repeated Chair Stands (RCS) Time
|
-1.888 seconds
Standard Error 0.588
|
0.826 seconds
Standard Error 0.551
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: All participants who received at least 1 dose of LY2495655 or placebo with evaluable uGS data.
Change from baseline to the 24-week endpoint in uGS is presented. Two attempts to walk a 4-meter distance were made. LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline uGS as covariate.
Outcome measures
| Measure |
LY2495655
n=80 Participants
Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
|
Placebo
n=85 Participants
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
|---|---|---|
|
Change From Baseline in Usual Gait Speed (uGS) at 4 Meters
|
0.030 meters per second (m/s)
Standard Error 0.017
|
0.013 meters per second (m/s)
Standard Error 0.017
|
Adverse Events
LY2495655
Serious events: 27 serious events
Other events: 90 other events
Deaths: 0 deaths
Placebo
Serious events: 18 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2495655
n=102 participants at risk
Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
|
Placebo
n=99 participants at risk
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Cardiac disorders
Sinoatrial block
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
General disorders
Device dislocation
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
General disorders
Injection site haemorrhage
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
General disorders
Pyrexia
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Epiglottitis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Pneumonia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.98%
1/102 • Number of events 2
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
2/102 • Number of events 2
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
2/102 • Number of events 2
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Investigations
International normalised ratio increased
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.98%
1/102 • Number of events 1
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.98%
1/102 • Number of events 1
|
0.00%
0/99
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/102
|
1.0%
1/99 • Number of events 1
|
Other adverse events
| Measure |
LY2495655
n=102 participants at risk
Participants received a 315-mg dose of LY2495655, administered SC, Q4W for 20 weeks.
|
Placebo
n=99 participants at risk
Participants received a LY2495655-matching dose of placebo, administered SC, Q4W for 20 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.9%
7/102 • Number of events 8
|
3.0%
3/99 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
6/102 • Number of events 8
|
7.1%
7/99 • Number of events 8
|
|
General disorders
Asthenia
|
3.9%
4/102 • Number of events 4
|
5.1%
5/99 • Number of events 5
|
|
General disorders
Fatigue
|
11.8%
12/102 • Number of events 14
|
3.0%
3/99 • Number of events 3
|
|
General disorders
Injection site bruising
|
5.9%
6/102 • Number of events 8
|
0.00%
0/99
|
|
General disorders
Injection site pain
|
19.6%
20/102 • Number of events 69
|
5.1%
5/99 • Number of events 7
|
|
General disorders
Pain
|
4.9%
5/102 • Number of events 5
|
6.1%
6/99 • Number of events 8
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
7/102 • Number of events 10
|
8.1%
8/99 • Number of events 8
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
3/102 • Number of events 3
|
6.1%
6/99 • Number of events 6
|
|
Injury, poisoning and procedural complications
Contusion
|
6.9%
7/102 • Number of events 9
|
9.1%
9/99 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.6%
19/102 • Number of events 20
|
13.1%
13/99 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.8%
11/102 • Number of events 11
|
4.0%
4/99 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.9%
7/102 • Number of events 9
|
3.0%
3/99 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
7/102 • Number of events 9
|
10.1%
10/99 • Number of events 10
|
|
Nervous system disorders
Headache
|
6.9%
7/102 • Number of events 8
|
4.0%
4/99 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
7/102 • Number of events 7
|
4.0%
4/99 • Number of events 5
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60