Acute Hip Fracture Study in Patients 65 Years or Greater | NCT02578095

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo QD	Drug: Placebo
VK5211- 0.5mg	Experimental	0.5mgQD	Drug: VK5211
VK5211- 1.0mg	Experimental	1.0mg QD	Drug: VK5211
VK5211- 2.0mg	Experimental	2.0mg QD	Drug: VK5211

Name	Type	Description	Arm Group Labels	Other Names
VK5211	Drug	Capsule	VK5211- 0.5mg VK5211- 1.0mg VK5211- 2.0mg

Measure	Description	Time Frame
Efficacy in Hip Fracture Patients Confirmed by DXA Scan.	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.	Baseline and Week12

Name	Affiliation	Role
Marianne Mancini	Viking Therapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Duurga Clinical Service		Yorba Linda	California	92886	United States
Orthopedic Research Institute

ID	Title	Description
FG000	Placebo	Placebo QD Placebo: Capsule
FG001	VK5211- 0.5mg	0.5mgQD VK5211: Capsule

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 23, 2015	Oct 29, 2025

ID	Title	Description
BG000	Placebo	Placebo QD Placebo: Capsule
BG001	VK5211- 0.5mg	0.5mgQD VK5211: Capsule
BG002	VK5211- 1.0mg	1.0mg QD VK5211: Capsule
BG003	VK5211- 2.0mg	2.0mg QD VK5211: Capsule
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00028 BG00129 BG00226 BG00325 BG004108

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG0031 events1 affected25 at risk
Atrial Fibrillation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Cardiac Failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Femur Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Hip Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Subdural Haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Thyroxine Decreased	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Cerebral Ischaemia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Cerebrovascular Accident	Nervous system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Transient Ischaemic Attack	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Confusional State	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Chronic Kidney Disease	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Haematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG0032 events2 affected25 at risk
Atrial Fibrillation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Cardiac Failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Cardiac Failure Congestive	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Cardiac Valve Disease	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Hypothyrodism	Endocrine disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Dry Mouth	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Oedema	General disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Oedema Peripheral	General disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Peripheral Swelling	General disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Urinary Tract Infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Facial Bones Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Femur Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Hip Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Rib Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Subdural Haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Alanine Aminotransferase Increase	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Aspartate Aminotransferase	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Blood Alkaline Phosphatase	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Hepatic Enzyme Increased	Investigations	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected29 at risk EG0021 events1 affected26 at risk EG003
International Normalised Ration Increased	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Liver Function Test Abnormal	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Thyroxine Decreased	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Vitamin D Decreased	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
White Blood Cells Urine Positive	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Abnormal Loss of Weight	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Vitamin D Deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0021 events1 affected26 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Pubic Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Soft Tissue Necrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Cerebral Ischaemia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Cerebrovascular Accident	Nervous system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0021 events1 affected26 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0021 events1 affected26 at risk EG003
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Syncope	Nervous system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Transient Ischaemic Attack	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Visual Field Defect	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Confusional State	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Chronic Kidney Disease	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Renal Failure	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Uterovaginal Prolapse	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0021 events1 affected26 at risk EG003
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Acne	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Dermatitis Allergic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected29 at risk EG0020 events0 affected26 at risk EG003
Circulatory Collapse	Vascular disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Haematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003
Thrombophlebitis	Vascular disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected29 at risk EG0020 events0 affected26 at risk EG003

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo QD Placebo: Capsule	28	4	28	10	28
EG001	VK5211- 0.5mg	0.5mgQD VK5211: Capsule	29	2	29	11	29
EG002	VK5211- 1.0mg	1.0mg QD VK5211: Capsule	26	3	26	8	26
EG003	VK5211- 2.0mg	2.0mg QD VK5211: Capsule	25	5	25	16	25