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CTRI Number  CTRI/2024/01/061919 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 29/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness and Safety of Cg-A1 Peptide in Patients with Muscle Atrophy 
Scientific Title of Study   A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study To Assess The Efficacy And Safety Of CG-A1 Peptide In Patients With Muscle Atrophy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BSR/CT/023/23, Version-1,20 Sep 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Datta  
Designation  Managing Director  
Affiliation  Biosite Research Private Limited. 
Address  1st Floor , Ajmera Nucleus, 424C, next to Mahindra Tech Park, Shanthipura, Electronic city Phase 2.

Bangalore
KARNATAKA
560100
India 
Phone  8026667707  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi Datta  
Designation  Managing Director  
Affiliation  Biosite Research Private Limited. 
Address  1st Floor , Ajmera Nucleus, 424C, next to Mahindra Tech Park, Shanthipura, Electronic city Phase 2.

Bangalore
KARNATAKA
560100
India 
Phone  8026667707  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Datta  
Designation  Managing Director  
Affiliation  Biosite Research Private Limited. 
Address  1st Floor , Ajmera Nucleus, 424C, next to Mahindra Tech Park, Shanthipura, Electronic city Phase 2.

Bangalore
KARNATAKA
560100
India 
Phone  8026667707  
Fax    
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
Caregen.Co., Ltd., Gyeonggi-do, Republic of Korea 
 
Primary Sponsor  
Name  Caregen.Co., Ltd 
Address  Gyeonggi-do, Republic of Korea 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Sudhakar  Excel Hospital  15 56-29, Near IG Statue, Beside Bharat Petroleum, Old Alwal , Secunderabad, Telangana 500010
Hyderabad
TELANGANA 		 9440664042

doctorresearch1212@gmail.com 
Dr Rohit Patel  Kanoria Hospital and Research Centre  Kanoria Hospital & Research Centre, Airport, Gandhinagar Highway, Village-Bhat, Gandhinagar-382428,
Gandhinagar
GUJARAT 		 9898072682

khrc111@gmail.com 
Dr Girish HR  Rajalakshmi Hospital and Research Center  Rajalakshmi Hospital and Research Center,21-1 Lakshmipura Main road, Vidyaranyapura Post-560097
Bangalore
KARNATAKA 		 8028393392

girirudra@yahoo.co.in 
Dr Rishabh Kumar  Sahaj Surgery  Sahaj Surgery, Tilak Nagar, Kankarbagh, Opposite Rejendra Nagar Terminal-800020
Patna
BIHAR 		 9835316417

drrishabh2005@gmail.com 
Dr Tarun Bali   Santosh Hospital  Santosh Hospital, 6 1, Promenode Road, Behind Coles Park, Bangalore-560055
Bangalore
KARNATAKA 		 9632144300

drtarunbali8@gmail.com 
DrHarshith N  Sunshine Healthcare Clinic  Sunshine Healthcare Clinic 2345, MIG, 16th B Main, LIG 3rd Stage, B Sector, Yelahanka New Town-560064
Bangalore
KARNATAKA 		 9844141315

harshithortho@gmail.com 
Dr Anupam Srivastava  Vatsalya Hospital Multispeciality Center  Vatsalya Hospital Multispeciality Center, S2 656, C4A Sikraul,221002
Varanasi
UTTAR PRADESH 		 9415227170

anudibya@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Excel Hospital Institutional Ethics Committee,  Approved 
Instituitional Ethics Committee Rajalakshmi Hospital  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee  Submittted/Under Review 
Kanoria Ethics Committee  Submittted/Under Review 
Santosh Institutional Ethics Committee  Submittted/Under Review 
Vatsalya Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  (Arginine+ Maltodextrin) 100 mg: Neutral supplement without active peptide   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 (i.e., a total of 200mg peptide per day). Visit I – Screening Baseline Visit Upto -7 days Visit II – Randomization Visit Day 0 Visit III –Interim Visit Week 4-Day 28± 4 days Visit IV –Interim Visit Week 8-Day 56 ± 4 days Visit V – End of Study Week 12-Day 84 ± 3 days. 
Intervention  (CG-A1 peptide + Arginine+ Maltodextrin) 100 mg: Peptide supplement  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 (i.e., a total of 200mg peptide per day). Visit I – Screening Baseline Visit Upto -7 days Visit II – Randomization Visit Day 0 Visit III –Interim Visit Week 4-Day 28± 4 days Visit IV –Interim Visit Week 8-Day 56 ± 4 days Visit V – End of Study Week 12-Day 84 ± 3 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  1. Presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes
mellitus etc.)
2. Presence of musculoskeletal or neurological disorders
3. Regular consumption of any analgesic or anti-inflammatory drug(s), either prescription or non-prescription
4. 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.
5. Recent (within 6 months) treatment with anabolic steroids.
6. 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.
d. Follows a kosher diet.
7. Medications
a. Use of appetite stimulants (including megestrol, dronabinol and cyproheptadine).
b. If participant is already taking a fish oil supplement, he or she must be willing to either stop the supplement.
8. 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
9. 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.
10. 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.
11. Women who plan to become pregnant during the study, are pregnant or lactating, or were pregnant or nursing within the past year.
12. 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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in muscle mass as assessed by DEXA Scan from
baseline to Week 12 		 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 
 
Secondary Outcome  
Outcome  TimePoints 
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
Change in Biomarkers
TNF-α, IL-6), IGF-1(Insulin-like growth factor-1), Sex hormones (testosterone, estrogen),
Creatine kinase (CK-MB), Aspartate aminotransferase, Troponin I, Myoglobin from baseline to
week 12 		 Trial participants shall be instructed to mix the contents of one sachet with approximately 100ml of water & consume after breakfast & the contents of a second sachet will be mixed with approximately 100ml water & consumed after dinner.
Time points- from
baseline to Week 12 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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