A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study To Assess The Efficacy And Safety Of CG-A1 Peptide In Patients With Muscle Atrophy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Change in muscle mass as assessed by DEXA Scan from
研究概览
简要总结
The study titled "A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study To Assess The Efficacy And Safety Of CG-A1 Peptide In Patients With Muscle Atrophy" is a Phase III clinical trial. The investigational medicinal product consists of CG-A1 peptide, arginine, and maltodextrin, and it aims to determine its effect on skeletal muscle atrophy and strength compared to a neutral supplement. The study includes 80 participants, with key inclusion criteria such as age 18 and above, muscle atrophy, low muscle strength, non-smoker status, normal vital signs, and BMI less than 25 kg/m². Exclusion criteria encompass uncontrolled systemic diseases, musculoskeletal or neurological disorders, recent anabolic steroid treatment, and dietary restrictions.
The use and administration involve a daily intake of the study medication, and participants will be monitored through clinic visits, physical examinations, vital signs measurements, and laboratory assessments. The study design includes randomization, with participants assigned to either the CG-A1 peptide group or the placebo group. Patients will undergo scheduled visits over 12 weeks, with assessments of muscle mass, functional mobility, strength, and biomarkers. Safety assessments include the evaluation of adverse events and serious adverse events throughout the study.The primary efficacy endpoint is the change in muscle mass as assessed by DEXA Scan from baseline to Week 12, while secondary endpoints encompass changes in functional mobility, strength, and various biomarkers. Safety assessments include the evaluation of adverse events and serious adverse events throughout the 12-week study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects who are 18 years of age and older of any ethnicity 2.Subjects with pathologic or physiologic muscle atrophy 3.Subjects with low muscle strength defined as less than 28 kg for men and less than18 kg for women assessed by hand dynamometer or low physical performance assessed by 6-meter walk test 6-meter walk less than 1m s 4.Non-smoker 5.Subjects who are accustomed to normal levels of physical activity except for bed ridden patients 6.Body mass index less than 25 kg m2 7.Vital signs are normal, or deemed abnormal but clinically insignificant by the Investigator 8.Clinical laboratory evaluations are normal or deemed clinically insignificant by the Investigator 9.Males who are sterile or agree to use an approved method of contraception, with an approved method of contraception considered a barrier method plus a contraceptive jelly.
- •If the female sexual partner of the male is using an approved form of contraception or is not of child-bearing potential, the male is not required to be sterile or, if not sterile, to use an approved form of contraception 10.Female subjects who are-Postmenopausal, Surgically sterilized ,WOCBP who are non-lactating and have been using an effective form of birth control for a minimum of 6 months prior to screening and agree to continue using the effective form of birth control during the study and for 30 days after the treatment period effective forms of birth control include oral pills with a concentration of at least 50 μg of the estrogenic component of a biphasic or triphasic pill, transdermal, injectable, or implantable contraceptive, intrauterine device and intrauterine system or double-barrier method WOCBP who are using low dose oral birth control must also use a barrier method of contraception for the duration of the study 11.Subjects who are capable of providing informed consent and complying with all study Procedures and requirements.
排除标准
- •Presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.)
- •Presence of musculoskeletal or neurological disorders
- •Regular consumption of any analgesic or anti-inflammatory drug(s), either prescription or non-prescription
- •Taking any medications known to affect protein metabolism (e.g. b-blockers, corticosteroids, non-steroidal anti- inflammatory, or prescription strength acne medications).
- •Additional medications and or supplementation aids (e.g. whey protein) will be deemed inappropriate based on the investigator’s discretion.
- •Dietary conditions a.
- •Diet restrictions including vegetarianism, veganism, soy-free diet, b.
- •Fish and or fish oil allergy or intolerance c.
- •Milk allergy excluding lactose intolerance.
- •Follows a kosher diet.
- •Medications a.
- •Use of appetite stimulants (including megestrol, dronabinol and cyproheptadine).
- •If participant is already taking a fish oil supplement, he or she must be willing to either stop the supplement.
- •Additional a.
- •Patient has implantable device such as a pacemaker or ICD b.
- •Hospitalization within the last 30 days c.
- •Living in a skilled nursing facility or long-term care facility
- •Participation in clinical trials human studies within 1 month of the start of this study and received other medicines or has applied other medical devices.
- •Person who is expected to receive other medicines or applied medical devices by participating in other clinical trials human studies during the participation period in this study.
- •Women who plan to become pregnant during the study, are pregnant or lactating, or were pregnant or nursing within the past year.
- •Subjects who have any condition or showing symptoms of a condition that would make them, in the opinion of the Investigator, unsuitable for the study.
结局指标
主要结局
Change in muscle mass as assessed by DEXA Scan from
时间窗: Trial participants shall be instructed to mix the contents of one sachet with approximately 100ml of water and consume after breakfast and the contents of a second sachet will be mixed with approximately 100ml water and consumed after dinner. | Time points- from | baseline to Week 12
baseline to Week 12
时间窗: Trial participants shall be instructed to mix the contents of one sachet with approximately 100ml of water and consume after breakfast and the contents of a second sachet will be mixed with approximately 100ml water and consumed after dinner. | Time points- from | baseline to Week 12
次要结局
- Change in the time to complete 6-meter walk test from baseline to Week 12(Change in hand grip strength test (hand dynamometer) from baseline to Week 12)
研究者
Dr Aditi Datta
Biosite Research Private Limited.