Trial Outcomes & Findings for Acute Hip Fracture Study in Patients 65 Years or Greater (NCT NCT02578095)
NCT ID: NCT02578095
Last Updated: 2025-12-29
Results Overview
Efficacy of VK5211 after 12 weeks of treatment by mean placebo-corrected percentage change in total body less head (TBLH) lean body mass assessed by whole body dual-energy x-ray absorptiometry scan (DXA) scan.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Baseline and Week12
Results posted on
2025-12-29
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo QD
Placebo: Capsule
|
VK5211- 0.5mg
0.5mgQD
VK5211: Capsule
|
VK5211- 1.0mg
1.0mg QD
VK5211: Capsule
|
VK5211- 2.0mg
2.0mg QD
VK5211: Capsule
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
26
|
25
|
|
Overall Study
COMPLETED
|
19
|
22
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
9
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Hip Fracture Study in Patients 65 Years or Greater
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
Placebo QD
Placebo: Capsule
|
VK5211- 0.5mg
n=29 Participants
0.5mgQD
VK5211: Capsule
|
VK5211- 1.0mg
n=26 Participants
1.0mg QD
VK5211: Capsule
|
VK5211- 2.0mg
n=25 Participants
2.0mg QD
VK5211: Capsule
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
76 Years
n=9 Participants
|
78 Years
n=6 Participants
|
78.5 Years
n=9 Participants
|
78 Years
n=205 Participants
|
78 Years
n=16 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=9 Participants
|
23 Participants
n=6 Participants
|
22 Participants
n=9 Participants
|
19 Participants
n=205 Participants
|
83 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
6 Participants
n=205 Participants
|
25 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
29 Participants
n=6 Participants
|
24 Participants
n=9 Participants
|
25 Participants
n=205 Participants
|
78 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
2 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
27 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week12Population: The ITT population was the primary analysis population for assessing efficacy.
Efficacy of VK5211 after 12 weeks of treatment by mean placebo-corrected percentage change in total body less head (TBLH) lean body mass assessed by whole body dual-energy x-ray absorptiometry scan (DXA) scan.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo QD
Placebo: Capsule
|
VK5211- 0.5mg
n=27 Participants
0.5mgQD
VK5211: Capsule
|
VK5211- 1.0mg
n=17 Participants
1.0mg QD
VK5211: Capsule
|
VK5211- 2.0mg
n=15 Participants
2.0mg QD
VK5211: Capsule
|
|---|---|---|---|---|
|
Efficacy in Hip Fracture Patients Confirmed by DXA Scan.
|
0 PBO adjusted percent change
Interval 0.0 to 0.0
|
4.75 PBO adjusted percent change
Interval 1.7 to 7.8
|
7.15 PBO adjusted percent change
Interval 3.76 to 10.54
|
9.08 PBO adjusted percent change
Interval 5.55 to 12.6
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
VK5211- 0.5mg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
VK5211- 1.0mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
VK5211- 2.0mg
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Placebo QD
Placebo: Capsule
|
VK5211- 0.5mg
n=29 participants at risk
0.5mgQD
VK5211: Capsule
|
VK5211- 1.0mg
n=26 participants at risk
1.0mg QD
VK5211: Capsule
|
VK5211- 2.0mg
n=25 participants at risk
2.0mg QD
VK5211: Capsule
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Investigations
Thyroxine Decreased
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Nervous system disorders
Cerebral Ischaemia
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Nervous system disorders
Transient Ischaemic Attack
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Psychiatric disorders
Confusional State
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Placebo QD
Placebo: Capsule
|
VK5211- 0.5mg
n=29 participants at risk
0.5mgQD
VK5211: Capsule
|
VK5211- 1.0mg
n=26 participants at risk
1.0mg QD
VK5211: Capsule
|
VK5211- 2.0mg
n=25 participants at risk
2.0mg QD
VK5211: Capsule
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Cardiac disorders
Tachycardia
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Endocrine disorders
Hypothyrodism
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
General disorders
Oedema
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
General disorders
Oedema Peripheral
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
General disorders
Peripheral Swelling
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
2/28 • Number of events 2 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Investigations
Alanine Aminotransferase Increase
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Investigations
Aspartate Aminotransferase
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Investigations
Blood Alkaline Phosphatase
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Investigations
Hepatic Enzyme Increased
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
16.0%
4/25 • Number of events 4 • 24 Weeks
|
|
Investigations
International Normalised Ration Increased
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Investigations
Thyroxine Decreased
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Investigations
Vitamin D Decreased
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Metabolism and nutrition disorders
Abnormal Loss of Weight
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pubic Pain
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Nervous system disorders
Cerebral Ischaemia
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
8.0%
2/25 • Number of events 2 • 24 Weeks
|
|
Nervous system disorders
Paraesthesia
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Nervous system disorders
Transient Ischaemic Attack
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Nervous system disorders
Visual Field Defect
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Psychiatric disorders
Confusional State
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Reproductive system and breast disorders
Uterovaginal Prolapse
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
1/28 • Number of events 1 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
8.0%
2/25 • Number of events 2 • 24 Weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/28 • 24 Weeks
|
3.4%
1/29 • Number of events 1 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
3.8%
1/26 • Number of events 1 • 24 Weeks
|
0.00%
0/25 • 24 Weeks
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
|
Cardiac disorders
Cardiac Valve Disease
|
0.00%
0/28 • 24 Weeks
|
0.00%
0/29 • 24 Weeks
|
0.00%
0/26 • 24 Weeks
|
4.0%
1/25 • Number of events 1 • 24 Weeks
|
Additional Information
Scott Stubbe, Vice President Clinical Operations
Viking Therapeutics, Inc
Phone: 8587044685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place