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.

Start Date30 Oct 2015

Sponsor / Collaborator

Viking Therapeutics, Inc.

100 Clinical Results associated with VK-5211

100 Translational Medicine associated with VK-5211

100 Patents (Medical) associated with VK-5211

Literatures (Medical) associated with VK-5211

17 Sep 2024·Cureus

LGD-4033 and a Case of Drug-Induced Liver Injury: Exploring the Clinical Implications of Off-Label Selective Androgen Receptor Modulator Use in Healthy Adults

Article

Author: Kim, Dolly O ; Labban, Harrison ; Paracha, Awais ; Islam, Mohammed ; Kwait, Brittany

Selective androgen receptor modulators (SARMs), designed to treat conditions such as muscle wasting and osteoporosis, are widely used among healthy adults seeking muscle hypertrophy and enhanced athletic performance, despite a lack of Food and Drug Administration (FDA) approval. This trend may be driven by the misconception that SARMs are safer alternatives to anabolic steroids. However, SARMs such as LGD-4033 (Ligandrol) are associated with significant adverse effects, including hepatotoxicity, cardiovascular complications, endocrine disturbances, and psychiatric symptoms. This report examines the clinical implications of off-label SARM use, focusing on a case of drug-induced liver injury (DILI) in a 52-year-old male. The patient presented with pruritic jaundice, significant weight loss, and elevated liver enzymes following three months of high-dose LGD-4033 use. A diagnostic workup ruled out other potential causes of liver injury, implicating SARM use as the likely etiology. This case underscores the necessity for heightened clinical vigilance, early diagnosis, and prompt intervention to mitigate serious health outcomes associated with SARM misuse.

30 Nov 2023·Rapid communications in mass spectrometry : RCM

Investigation of in vitro generated metabolites of LGD-4033, a selective androgen receptor modulator, in homogenized camel liver for anti-doping applications.

Article

Author: Ondern Komathu, Praseen ; Palathinkal, Ansar Babu ; Laya, Saraswathy ; Nelliyott, Ibrahimwaseem ; Nalakath, Jahfar ; Padusha, Mohamed Khan Syed Ali

RATIONALEThe use of selective androgen receptor modulators (SARM) in sports is prohibited by the World Anti-Doping Agency (WADA) due to their potential as performance-enhancing drugs, offering an unfair advantage. LGD-4033 is a SARM known for its similarities to anabolic steroids and can be easily purchased online, leading to increased availability and misuse. Adverse analytical findings have revealed the presence of SARMs in dietary supplements. Although LGD-4033 misuse has been reported in human sports over the years, concerns also arise regarding its illicit use in animal sports, including camel racing. Although various studies have investigated the metabolism of LGD-4033 in humans, horse, and other species, there is limited research specifically dedicated to racing camels.METHODSThis study focuses on the in vitro metabolism of LGD-4033 in homogenized camel liver using liquid chromatography-high-resolution mass spectrometry (LC-HRMS) to identify and characterize the metabolites.RESULTSThe findings indicated the presence of 12 phase I metabolites and 1 phase II metabolite. Hydroxylation was responsible for the formation of the main phase I metabolites that were identified. A glucuronic acid conjugate of the parent drug was observed in this study, but no sulfonic acid conjugate was found. The possible chemical structures of these metabolites, along with their fragmentation patterns, were identified using MS.CONCLUSIONSThese findings provide valuable insights into the metabolism of LGD-4033 in camels and aid in the development of effective doping control methods for the detection of SARMs in camel racing.

01 Nov 2023·Journal of Bone and Mineral Metabolism

Effects of ligandrol as a selective androgen receptor modulator in a rat model for osteoporosis

Article

Author: Saul, Dominik ; Roch, Paul J ; Müller-Reiter, Max ; Lehmann, Wolfgang ; Schilling, Arndt F ; Hoffmann, Daniel B ; Hawellek, Thelonius ; Taudien, Stefan ; Böker, Kai O ; Derout, Christoph ; Sehmisch, Stephan ; Komrakova, Marina

INTRODUCTIONThe selective androgen receptor modulator ligandrol (LGD-4033 or VK5211) has been shown to improve muscle tissue. In the present study, the effect of ligandrol on bone tissue was investigated in ovariectomized rat model.MATERIALS AND METHODSThree-month-old Sprague Dawley rats were either ovariectomized (OVX, n = 60) or left intact (NON-OVX, n = 15). After 9 weeks, OVX rats were divided into four groups: untreated OVX (n = 15) group and three OVX groups (each of 15 rats) treated with ligandrol orally at doses of 0.03, 0.3, or 3 mg/kg body weight. After five weeks, lumbar vertebral bodies (L), tibiae, and femora were examined using micro-computed tomographical, biomechanical, ashing, and gene expression analyses.RESULTSIn the 3-mg ligandrol group, bone structural properties were improved (trabecular number: 38 ± 8 vs. 35 ± 7 (femur), 26 ± 7 vs. 22 ± 6 (L), 12 ± 5 vs. 6 ± 3 (tibia) and serum phosphorus levels (1.81 ± 0.17 vs.1.41 ± 0.17 mmol/l), uterus (0.43 ± 0.04 vs. 0.11 ± 0.02 g), and heart (1.13 ± 0.11 vs. 1.01 ± 0.08 g) weights were increased compared to the OVX group. Biomechanical parameters were not changed. Low and medium doses did not affect bone tissue and had fewer side effects. Body weight and food intake were not affected by ligandrol; OVX led to an increase in these parameters and worsened all bone parameters.CONCLUSIONLigandrol at high dose showed a subtle anabolic effect on structural properties without any improvement in biomechanical properties of osteoporotic bones. Considering side effects of ligandrol at this dose, its further investigation for the therapy of postmenopausal osteoporosis should be reevaluated.

100 Deals associated with VK-5211

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Fractures, Bone	Phase 2	-	Ligand Pharmaceuticals, Inc.	-
Muscular Atrophy	Phase 1	US	Viking Therapeutics, Inc.	12 Aug 2021
Hip Fractures	Phase 1	US	Viking Therapeutics, Inc.	30 Oct 2015
Hip Fractures	Phase 1	RO	Viking Therapeutics, Inc.	30 Oct 2015
Hip Fractures	Phase 1	HU	Viking Therapeutics, Inc.	30 Oct 2015
Cachexia	Preclinical	US	Viking Therapeutics, Inc.	-
Hypogonadism	Preclinical	US	Viking Therapeutics, Inc.	-
Osteoporosis	Preclinical	US	Viking Therapeutics, Inc.	-

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