A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients with Sarcopenia - Sarcopenia Study

Phase 1

• Conditions: Sarcopenia; MedDRA version: 9.1 Level: LLT Classification code 10063024 Term: Sarcopenia

• Registration Number: EUCTR2007-002383-95-GB
• Lead Sponsor: Merck & Co Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-01
• Study Completion: 2009-10-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Patient is a woman 65 years of age on day of signing the informed consent.
2. Patient has an aLBM/Ht2, measured by DEXA, > 1 SD below the mean of a healthy
young adult population (peak).
3. Patient has self-reported difficulty in climbing 10 steps or walking ¼ mile outside on level ground without resting, or an AM-PAC physical movement score <66.
4. Patient has an SPPB score that is 1-9.
5. Patient is mentally competent - has scored =21 on the Folstein's Estate Examination (MMSE) at screening (Visit 1) and in the opinion of the Investigator is able to understand and follow study procedures.
6. Patient is judged to be in satisfactory health based on medical history, physical examination, ECG, and laboratory screening evaluations.
7. Patient has adequate organ function as indicated by the following laboratory values (Table 2-1) at screening (Visit 1):
8. Patient liver function tests are all within the normal range.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient has:
•neuromuscular diseases (Parkinson's disease, amyotrophic lateral sclerosis, stroke affecting lower extremity function & muscular dystrophy), rheumatoid arthritis, conditions causing significant muscular/joint pain or significantly limits mobility (e.g. polymyalgia rheumatica, polymyositis, & fibromyalgia). Patient with conditions like osteoarthritis can participate unless pain limits performing study procedures. Patients with polymyalgia affecting only limited parts of upper body (i.e. neck, shoulder) can participate.
•chronic lung disease limiting mobility due to respiratory function, or has another condition that impacts assessing improved muscle strength/ function, or has epilepsy, multiple sclerosis or focal lesions.
•axis I psychiatric disorders in the 6 months prior to screening
•inadequately treated depression or mental/legal incapacitation, or significant emotional problems at study start.
•another neurological/psychiatric condition affecting ability to give informed consent and/or can impact cognitive function.
•unstable angina or NYHA Class III or IV congestive heart failure or has uncontrolled hypertension (i.e., sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mm Hg).
•clinically significant postural hypotension (i.e., drop of 20 mm Hg in systolic blood pressure or increase of 20 beats/minute after 5 mins standing).
•a history of marked baseline prolongation of QT/QTc interval, or additional risk factors for Torsades de Pointes, or concomitant use of medications prolonging QT/QTc interval.
•symptomatic peripheral arteriovascular disease likely to affect patients' mobility & ability to perform study procedures
•significant cardiovascular disease, including any known history of myocardial infarction.
•history of any cancer, except: adequately treated superficial basal or squamous cell carcinoma of skin or cervical carcinoma in situ; or solid tumor definitively treated without history of recurrence for at least 5 years prior to screening.
•taken anabolic steroids, dehydroepiandrosterone, androstenedione, any drug altering testosterone metabolism within 12 months before screening or rGH in the 12 months prior to screening. Tamoxifen also prohibited due to its suppressive effects on androgen levels.
•taken glucocorticoids at supraphysiological doses within 2 months before screening . Inhaled & topical glucocorticoids not excluded.
•taken strong inhibitor/inducer of CYP3A4, within 2 weeks before screening or anticipates using these during study.
•taken neuroleptic medications in the 6 months prior to screening. Hypnotics not excluded. Taking parathyroid hormone or vitamin D active metabolites.
•Cushing's syndrome or disease not cured for at least 12 months, or has Addison's disease.
•had bilateral adrenalectomy or any vestibular disorders.
•requires walking aid to perform study procedures. Patients using walking aids are allowed in the study; however they must be able to perform most study procedures without an assistive device. It is permissible for the patient to use a walking device for the SPPB if she's not comfortable performing walk test without assistive device.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified