A Phase II, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Multi-Center Study to Explore the Efficacy, Safety and Tolerability of VK5211 in Subjects With Acute Hip Fracture

Viking Therapeutics, Inc.21 sites in 4 countries108 target enrollmentOctober 30, 2015

ConditionsHip Fractures

InterventionsPlacebo VK5211

DrugsVK5211 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Hip Fractures
Sponsor: Viking Therapeutics, Inc.
Enrollment: 108
Locations: 21
Primary Endpoint: Efficacy in Hip Fracture Patients Confirmed by DXA Scan.
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 30, 2015

End Date

December 17, 2017

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Viking Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation.

Exclusion Criteria

•Pathological fracture (e.g. fracture due to Paget's disease of bone, malignancy, etc.). Fracture due to postmenopausal osteoporosis is not considered pathological for this trial.

Arms & Interventions

Placebo

Placebo QD

Intervention: Placebo

VK5211- 0.5mg

0.5mgQD

Intervention: VK5211

VK5211- 1.0mg

1.0mg QD

Intervention: VK5211

VK5211- 2.0mg

2.0mg QD

Intervention: VK5211

Outcomes

Primary Outcomes

Efficacy in Hip Fracture Patients Confirmed by DXA Scan.

Time Frame: Baseline and Week12

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.