Phase 2 N=108 Randomized Quadruple-blind Treatment

Acute Hip Fracture Study in Patients 65 Years or Greater

Hip Fractures

Bottom Line

View on ClinicalTrials.gov: NCT02578095 ↗

Enrolled (actual)

108

Serious AEs

13.0%

Results posted

Dec 2025

Primary outcome: Primary: Efficacy in Hip Fracture Patients Confirmed by DXA Scan. — 0; 4.75; 7.15; 9.08 PBO adjusted percent change — p=0.0032

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: VK5211 (Drug); Placebo (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Viking Therapeutics, Inc.
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy in Hip Fracture Patients Confirmed by DXA Scan.	0; 4.75; 7.15; 9.08	0.0032 sig

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02578095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.