Hip FracturesPhase 2NCT02578095

Acute Hip Fracture Study in Patients 65 Years or Greater

A Phase 2 study testing VK5211 in people with Hip Fractures, run by Viking Therapeutics, Inc. at 21 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Hip Fractures
What is being tested?: VK5211
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 21 sitesin 4 countries
Study dates: 30 Oct 2015to 17 Dec 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

21 sites in 4 countries.

Country

City, postcode or hospital

21 sites in 4 countries

United States7 sites

Orthopedic Research Institute
Boynton Beach, Florida, 33472
Infinite Clinical Research
Doral, Florida, 33126
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, 33136
Center for Advanced Research & Education
Gainesville, Georgia, 30501
Orthopaedic Association of Michigan
Grand Rapids, Michigan, 49525
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, 53705
Duurga Clinical Service
Yorba Linda, California, 92886

Other trials in United States

Hungary6 sites

Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály
Budapest, 1125
MH Egészségügyi Központ Baleseti Sebészeti Osztály
Budapest
Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály
Budapest
Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály
Győr, 9024
Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály
Nyíregyháza, 4400
SZTE ÁOK Traumatológiai Klinika
Szeged, 6725

Other trials in Hungary

Serbia5 sites

Institut za Ortopedsko-hirurške bolesti Banjica
Belgrade, 11000
Klinički Centar Srbije
Belgrade, 11000
Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology
Belgrade, 11080
Clinical Center Kragujevac Department for Orthopedics and Traumatology
Kragujevac, 34000
Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology
Novi Sad, 21000

Other trials in Serbia

Romania3 sites

Spitalul Clinic de Urgenta Bucuresti ("Floreasca")
Bucharest, 014461
Spitalul Universitar de Urgenţă
Bucharest, 050098
Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon
Iași, 700111

Other trials in Romania

About this study

Official title: 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

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.

Conditions: Hip Fractures
Being tested: VK5211, Placebo
Medical subject headings: Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VK5211Drug
Capsule
PlaceboDrug
Capsule

Study groups in NCT02578095
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo QD Receives: Drug: Placebo
VK5211- 0.5mg	Experimental	0.5mgQD Receives: Drug: VK5211
VK5211- 1.0mg	Experimental	1.0mg QD Receives: Drug: VK5211
VK5211- 2.0mg	Experimental	2.0mg QD Receives: Drug: VK5211

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201517 Dec 2017

First posted16 Oct 2015 (estimated)
Study start30 Oct 2015
Primary completion15 Nov 2017
Study completion17 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hip FracturesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02578095
Sponsor's protocol ID: VK5211-201
Status last verified: Dec 2025
First submitted: 13 Oct 2015
Last updated: 29 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

All Hip Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02578095
Acronym / sponsor ID: VK5211-201
Conditions: Hip Fractures
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 30 Oct 2015 (actual)
Primary completion: 15 Nov 2017 (actual)
Study completion: 17 Dec 2017 (actual)
First posted: 16 Oct 2015 (estimated)
Results: Posted 29 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo QD
VK5211- 0.5mg	Experimental	Drug: VK52110.5mgQD
VK5211- 1.0mg	Experimental	Drug: VK52111.0mg QD
VK5211- 2.0mg	Experimental	Drug: VK52112.0mg QD

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VK5211Capsule	Drug	VK5211- 0.5mg, VK5211- 1.0mg, VK5211- 2.0mg
PlaceboCapsule	Drug	Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 29 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	28	19
VK5211- 0.5mg	29	22
VK5211- 1.0mg	26	17
VK5211- 2.0mg	25	17

Primary outcome: Efficacy in Hip Fracture Patients Confirmed by DXA Scan.

Time frame: Baseline and Week12. Least squares mean (95% Confidence Interval). Unit: PBO adjusted percent change

Measure	Placebo n = 20	VK5211- 0.5mg n = 27	VK5211- 1.0mg n = 17	VK5211- 2.0mg n = 15
Value	0 (0 to 0)	4.75 (1.70 to 7.80)	7.15 (3.76 to 10.54)	9.08 (5.55 to 12.60)

Placebo vs VK5211- 0.5mg: Mean Difference (Final Values): 4.75 (95% CI 1.70 to 7.80), p = 0.0032, ANCOVA
Placebo vs VK5211- 1.0mg: Mean Difference (Final Values): 7.15 (95% CI 3.76 to 10.54), p <0.0001, ANCOVA
Placebo vs VK5211- 2.0mg: Mean Difference (Final Values): 9.08 (95% CI 5.55 to 12.60), p <0.0001, ANCOVA

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

Adverse events

Time frame: 24 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 28 (14.3%)	10 of 28 (35.7%)	0 of 28
VK5211- 0.5mg	2 of 29 (6.9%)	11 of 29 (37.9%)	0 of 29
VK5211- 1.0mg	3 of 26 (11.5%)	8 of 26 (30.8%)	0 of 26
VK5211- 2.0mg	5 of 25 (20%)	16 of 25 (64%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hip Fractures

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marianne Mancini study director

Viking Therapeutics, Inc.

21 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VK5211 in people with Hip Fractures, run by Viking Therapeutics, Inc. at 21 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Hungary, Serbia, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy in Hip Fracture Patients Confirmed by DXA Scan. (time frame: Baseline and Week12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02578095.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.