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Acute Hip Fracture Study in Patients 65 Years or Greater
Phase 2 trial testing VK5211 in Hip Fractures in 108 participants. Completed in 17 December 2017.
| Lead sponsor | Viking Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 30 October 2015 |
| Primary completion | 15 November 2017 |
| Estimated completion | 17 December 2017 |
| Sites | 21 locations across Serbia, Romania, United States, Hungary |
Viking Therapeutics, Inc. — full company profile →
65 and older, any sex, with Hip Fractures. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0 | 0 – 0 |
| VK5211- 0.5mg | 4.75 | 1.70 – 7.80 |
| VK5211- 1.0mg | 7.15 | 3.76 – 10.54 |
| VK5211- 2.0mg | 9.08 | 5.55 – 12.60 |
Time frame: 24 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | VK5211- 0.5mg | VK5211- 1.0mg | VK5211- 2.0mg |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — | — | — |
| Cardiac Failure | Cardiac disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — |
| Femur Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Hip Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Subdural Haematoma | Injury, poisoning and procedural complications | — | — | — | — |
| Thyroxine Decreased | Investigations | — | — | — | — |
| Cerebral Ischaemia | Nervous system disorders | — | — | — | — |
| Cerebrovascular Accident | Nervous system disorders | — | — | — | — |
| Transient Ischaemic Attack | Nervous system disorders | — | — | — | — |
| Confusional State | Psychiatric disorders | — | — | — | — |
| Chronic Kidney Disease | Renal and urinary disorders | — | — | — | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Haematoma | Vascular disorders | — | — | — | — |
| Reaction | System | Placebo | VK5211- 0.5mg | VK5211- 1.0mg | VK5211- 2.0mg |
|---|---|---|---|---|---|
| Hepatic Enzyme Increased | Investigations | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — | — | — |
| Cardiac Failure | Cardiac disorders | — | — | — | — |
| Cardiac Failure Congestive | Cardiac disorders | — | — | — | — |
| Cardiac Valve Disease | Cardiac disorders | — | — | — | — |
| Palpitations | Cardiac disorders | — | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — | — |
| Hypothyrodism | Endocrine disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Dry Mouth | Gastrointestinal disorders | — | — | — | — |
| Haematochezia | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Oedema | General disorders | — | — | — | — |
| Oedema Peripheral | General disorders | — | — | — | — |
| Peripheral Swelling | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — |
| Urinary Tract Infection | Infections and infestations | — | — | — | — |
| Facial Bones Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Femur Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Hip Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Joint Injury | Injury, poisoning and procedural complications | — | — | — | — |
| Laceration | Injury, poisoning and procedural complications | — | — | — | — |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Procedural Pain | Injury, poisoning and procedural complications | — | — | — | — |
| Rib Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Subdural Haematoma | Injury, poisoning and procedural complications | — | — | — | — |
| Alanine Aminotransferase Increase | Investigations | — | — | — | — |
| Aspartate Aminotransferase | Investigations | — | — | — | — |
| Blood Alkaline Phosphatase | Investigations | — | — | — | — |
| International Normalised Ration Increased | Investigations | — | — | — | — |
| Liver Function Test Abnormal | Investigations | — | — | — | — |
| Thyroxine Decreased | Investigations | — | — | — | — |
Most-reported serious reactions: Anaemia, Atrial Fibrillation, Cardiac Failure, Pneumonia, Sepsis, Femur Fracture, Hip Fracture, Subdural Haematoma.
Data from ClinicalTrials.gov NCT02578095 adverse events section.
This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment. Males and females ≥65 years old who are ambulatory and recovering from a hip fracture will be eligible for participation 3-7 weeks post-injury.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02578095.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing