selective androgen receptor modulators (SARMs) study on improving muscle mass

[Presser]

[h=1]Note: I do believe they stopped clinical trials after this study, and never moved on to phase two of trials, or maybe after phase two it stopped, but they put an end to it for whatever reason!


Selective androgen receptor modulators for the prevention and treatment of muscle wasting associated with cancer.[/h]

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[h=3]Abstract[/h][h=4]PURPOSE OF REVIEW:[/h]<abstracttext label="PURPOSE OF REVIEW" nlmcategory="OBJECTIVE">This review highlights selective androgen receptor modulators (SARMs) as emerging agents in late-stage clinical development for the prevention and treatment of muscle wasting associated with cancer.</abstracttext>
[h=4]RECENT FINDINGS:[/h]<abstracttext label="RECENT FINDINGS" nlmcategory="RESULTS">Muscle wasting, including a loss of skeletal muscle, is a cancer-related symptom that begins early in the progression of cancer and affects a patient's quality of life, ability to tolerate chemotherapy, and survival. SARMs increase muscle mass and improve physical function in healthy and diseased individuals, and potentially may provide a new therapy for muscle wasting and cancer cachexia. SARMs modulate the same anabolic pathways targeted with classical steroidal androgens, but within the dose range in which expected effects on muscle mass and function are seen androgenic side-effects on prostate, skin, and hair have not been observed. Unlike testosterone, SARMs are orally active, nonaromatizable, nonvirilizing, and tissue-selective anabolic agents.</abstracttext>
[h=4]SUMMARY:[/h]<abstracttext label="SUMMARY" nlmcategory="CONCLUSIONS">Recent clinical efficacy data for LGD-4033, MK-0773, MK-3984, and enobosarm (GTx-024, ostarine, and S-22) are reviewed. Enobosarm, a nonsteroidal SARM, is the most well characterized clinically, and has consistently demonstrated increases in lean body mass and better physical function across several populations along with a lower hazard ratio for survival in cancer patients. Completed in May 2013, results for the Phase III clinical trials entitled Prevention and treatment Of muscle Wasting in patiEnts with Cancer1 (POWER1) and POWER2 evaluating enobosarm for the prevention and treatment of muscle wasting in patients with nonsmall cell lung cancer will be available soon, and will potentially establish a SARM, enobosarm, as the first drug for the prevention and treatment of muscle wasting in cancer patients.</abstracttext>

 

[Presser]

I stand corrected in the case of SARM "Enobosarm"




Study Design and Rationale for the Phase 3 Clinical Development Program of Enobosarm, a Selective Androgen Receptor Modulator, for the Prevention and Treatment of Muscle Wasting in Cancer Patients (POWER Trials).Crawford J1, Prado CM2, Johnston MA3, Gralla RJ4, Taylor RP3, Hancock ML3, Dalton JT5.Author informationAbstractMuscle wasting in cancer is a common and often occult condition that can occur prior to overt signs of weight loss and before a clinical diagnosis of cachexia can be made. Muscle wasting in cancer is an important and independent predictor of progressive functional impairment, decreased quality of life, and increased mortality. Although several therapeutic agents are currently in development for the treatment of muscle wasting or cachexia in cancer, the majority of these agents do not directly inhibit muscle loss.

Selective androgen receptor modulators (SARMs) have the potential to increase lean body mass (LBM) and hence muscle mass, without the untoward side effects seen with traditional anabolic agents.

Enobosarm, a nonsteroidal SARM, is an agent in clinical development for prevention and treatment of muscle wasting in patients with cancer (POWER 1 and 2 trials). The POWER trials are two identically designed randomized, double-blind, placebo-controlled, multicenter, and multinational phase 3 trials to assess the efficacy of enobosarm for the prevention and treatment of muscle wasting in subjects initiating first-line chemotherapy for non-small-cell lung cancer (NSCLC). To assess enobosarm's effect on both prevention and treatment of muscle wasting, no minimum weight loss is required. These pivotal trials have pioneered the methodological and regulatory fields exploring a therapeutic agent for cancer-associated muscle wasting, a process hereby described.

In each POWER trial, subjects will receive placebo (n = 150) or enobosarm 3 mg (n = 150) orally once daily for 147 days.

Physical function, assessed as stair climb power (SCP), and LBM, assessed by dual-energy X-ray absorptiometry (DXA), are the co-primary efficacy endpoints in both trials assessed at day 84. Based on extensive feedback from the US Food and Drug Administration (FDA), the co-primary endpoints will be analyzed as a responder analysis. To be considered a physical function responder, a subject must have ≥10 % improvement in physical function compared to baseline.

To meet the definition of response on LBM, a subject must have demonstrated no loss of LBM compared with baseline.

Secondary endpoints include durability of response assessed at day 147 in those responding at day 84.

A combined overall survival analysis for both studies is considered a key secondary safety endpoint. The POWER trials design was established with extensive clinical input and collaboration with regulatory agencies.

The efficacy endpoints are a result of this feedback and discussion of the threshold for clinical benefit in patients at risk for muscle wasting. Full results from these studies will soon be published and will further guide the development of future anabolic trials.



Clinical Trial ID: NCT01355484. https://clinicaltrials.gov/ct2/show/NCT01355484 , NCT01355497. https://clinicaltrials.gov/ct2/show/NCT01355497?term=g300505&rank=1 .

 

[Presser]

decent study and read for those new to sarms and muscle building

 

[gandhisays]

will musclechem store carry cardarine any time soon? or any other peptides, sarm or serms?

 

[Presser]

BUMPING THIS READ TO THE TOP

 

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Muscle Wasting Study / Publication Showing Selective Androgen Receptor Modulators Impact and Ability to Build Muscle and Spare Muscle

 

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solid read, and a ton more actual SARM studies available in Articles forum here at Muscle Chem

 

[Presser]

will musclechem store carry cardarine any time soon? or any other peptides, sarm or serms?

Nope! I think we have everything we need for now.