FindTrial
Sign In

Acute Hip Fracture Study in Patients 65 Years or Greater

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02578095
Enrollment
108
Registered
2015-10-16
Start date
2015-10-30
Completion date
2017-12-17
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

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.

Interventions

DRUGVK5211

Capsule

DRUGPlacebo

Capsule

Sponsors

Viking Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy in Hip Fracture Patients Confirmed by DXA Scan.Baseline and Week12Efficacy 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.

Countries

Hungary, Romania, Serbia, United States

Participant flow

Participants by arm

ArmCount
Placebo
Placebo QD Placebo: Capsule
28
VK5211- 0.5mg
0.5mgQD VK5211: Capsule
29
VK5211- 1.0mg
1.0mg QD VK5211: Capsule
26
VK5211- 2.0mg
2.0mg QD VK5211: Capsule
25
Total108

Baseline characteristics

CharacteristicPlaceboTotalVK5211- 2.0mgVK5211- 1.0mgVK5211- 0.5mg
Age, Continuous76 Years78 Years78 Years78.5 Years78 Years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants78 Participants25 Participants24 Participants29 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
27 Participants27 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
19 Participants83 Participants19 Participants22 Participants23 Participants
Sex: Female, Male
Male
9 Participants25 Participants6 Participants4 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 290 / 260 / 25
other
Total, other adverse events
10 / 2811 / 298 / 2616 / 25
serious
Total, serious adverse events
4 / 282 / 293 / 265 / 25

Outcome results

Primary

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.

Time frame: Baseline and Week12

Population: The ITT population was the primary analysis population for assessing efficacy.

ArmMeasureValue (LEAST_SQUARES_MEAN)
PlaceboEfficacy in Hip Fracture Patients Confirmed by DXA Scan.0 PBO adjusted percent change
VK5211- 0.5mgEfficacy in Hip Fracture Patients Confirmed by DXA Scan.4.75 PBO adjusted percent change
VK5211- 1.0mgEfficacy in Hip Fracture Patients Confirmed by DXA Scan.7.15 PBO adjusted percent change
VK5211- 2.0mgEfficacy in Hip Fracture Patients Confirmed by DXA Scan.9.08 PBO adjusted percent change
p-value: 0.003295% CI: [1.7, 7.8]ANCOVA
p-value: <0.000195% CI: [3.76, 10.54]ANCOVA
p-value: <0.000195% CI: [5.55, 12.6]ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026