NCT02578095

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2015

Geographic Reach
4 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

October 30, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2017

Completed
8 years until next milestone

Results Posted

Study results publicly available

December 29, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

October 13, 2015

Results QC Date

October 30, 2025

Last Update Submit

December 24, 2025

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and Week12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo QD

Drug: Placebo

VK5211- 0.5mg

EXPERIMENTAL

0.5mgQD

Drug: VK5211

VK5211- 1.0mg

EXPERIMENTAL

1.0mg QD

Drug: VK5211

VK5211- 2.0mg

EXPERIMENTAL

2.0mg QD

Drug: VK5211

Interventions

VK5211DRUG

Capsule

VK5211- 0.5mgVK5211- 1.0mgVK5211- 2.0mg
PlaceboDRUG

Capsule

Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Duurga Clinical Service

Yorba Linda, California, 92886, United States

Location

Orthopedic Research Institute

Boynton Beach, Florida, 33472, United States

Location

Infinite Clinical Research

Doral, Florida, 33126, United States

Location

Shrock Orthopedic Research, LLC

Fort Lauderdale, Florida, 33136, United States

Location

Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States

Location

Orthopaedic Association of Michigan

Grand Rapids, Michigan, 49525, United States

Location

University of Wisconsin Osteoporosis Clinical Research Program

Madison, Wisconsin, 53705, United States

Location

Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály

Budapest, 1125, Hungary

Location

MH Egészségügyi Központ Baleseti Sebészeti Osztály

Budapest, Hungary

Location

Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály

Budapest, Hungary

Location

Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály

Győr, 9024, Hungary

Location

Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály

Nyíregyháza, 4400, Hungary

Location

SZTE ÁOK Traumatológiai Klinika

Szeged, 6725, Hungary

Location

Spitalul Clinic de Urgenta Bucuresti ("Floreasca")

Bucharest, 014461, Romania

Location

Spitalul Universitar de Urgenţă

Bucharest, 050098, Romania

Location

Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon

Iași, 700111, Romania

Location

Institut za Ortopedsko-hirurške bolesti Banjica

Belgrade, 11000, Serbia

Location

Klinički Centar Srbije

Belgrade, 11000, Serbia

Location

Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac Department for Orthopedics and Traumatology

Kragujevac, 34000, Serbia

Location

Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology

Novi Sad, 21000, Serbia

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Results Point of Contact

Title
Scott Stubbe, Vice President Clinical Operations
Organization
Viking Therapeutics, Inc
sstubbe@vikingtherapeutics.com
8587044685

Study Officials

  • Marianne Mancini

    Viking Therapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 16, 2015

Study Start

October 30, 2015

Primary Completion

November 15, 2017

Study Completion

December 17, 2017

Last Updated

December 29, 2025

Results First Posted

December 29, 2025

Record last verified: 2025-12

Locations

HU(6)RO(3)US(7)SE(5)