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CTRI Number  CTRI/2025/01/078994 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Study of Korglutide in Weight Management in Obese Individuals With and Without Type 2 Diabetes. 
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy and Safety of CG-DL (Korglutide) in Weight Management in Obese Individuals with and without Type 2 Diabetes 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BSR/CT/013/24, Version-1.0,10 Oct 2024   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 Building, 46-38, LS-ro 91beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea (Post Code)14119 
 
Primary Sponsor  
Name  Biosite Research private Limited 
Address  1st Floor, Ajmera Nucleus, 424C, Next to Mahindra Tech Park, Shanthipura, Electronic City Phase 2, Bengaluru, Karnataka 560100 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
Caregen Co Ltd   Gyeonggi-do Republic of Korea  
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavita Kadian  Infinity Care Hospital  Tagore Town, Panchkoshi Road, Varanasi 221005
Varanasi
UTTAR PRADESH 		 8527756290

kavitakadian91@gmail.com 
Dr Madhusudhan R L  Lalitha Clinic  Lalitha Clinic, No 164, 8th cross, 34th Main, ITI Layout, Indira Gandhi Circle, J.P. Nagar 1st Phase,Bengaluru-560078
Bangalore
KARNATAKA 		 9945042773

lalithahealthcare18@gmail.com 
Dr Rashmi G R  Nano Hospitals  Nano Hospitals, # 79, Sir M Visveswaraya Road, Near Arekere Sai Baba Temple, Off Bannerghatta Road,Bengaluru – 560076.
Bangalore
KARNATAKA 		 9632588967

clinicalresearchstudies23@gmail.com 
Dr Bhole Pushkaraja Santosh  Signus Hospital  5th Floor, Atlanta Shoppers, Pathardi Phata, Pathari Road, Nashik- 422010
Nashik
MAHARASHTRA 		 8806107709

bholepushkaraj@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Infinity Care Hospital Ethics Committee  Approved 
Signus Hospital Ethics Committee  Approved 
Sri Durgamba Independent Ethics Committee  Approved 
Sri Durgamba Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CG-DL (Korglutide)  Patients instructed to mix the contents of one sachet with approximate 100mL water and consumed at any time of day, with or without meals. If a dose is missed, treatment should be continued with the next dose as planned. Total treatment duration of the study - 12 weeks 
Comparator Agent  Matching placebo  Patients instructed to mix the contents of one sachet with approximate 100mL water and consumed at any time of day, with or without meals. Total treatment duration of the study - 12 weeks If a dose is missed, treatment should be continued with the next dose as planned. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adults male and female subjects aged 18 to 65 years at the time of screening
2.Body Mass Index BMI
Non-diabetic cohort BMI more than equal to 30 kg per meter square
Diabetic cohort Type 2 Diabetes BMI more than equal to 27 kg per meter square
3.Type 2 Diabetes Mellitus Diabetic Cohort
Diagnosed at least 6 months prior to screening
Glycated hemoglobin HbA1c between 7.0 percent and 10.0 Percent at screening.
On a stable regimen of oral antidiabetic drugs OADs or insulin for at least 3 months before randomization.
4. Demonstrates a stable body weight Pulse or Minus 5 kg for at least 3 months before screening
5. Waist Circumference more than equal to 88 cm in women; more than equal to 102 cm in men.
6. Must follow a calorie-controlled diet and be willing to adhere to physical activity recommendations during the trial.
7. Subjects must provide signed and dated informed consent before screening procedures. 
 
ExclusionCriteria 
Details  1. Women who are pregnant, planning to become pregnant during the study, or currently breastfeeding will be excluded. Female subjects of childbearing potential must have a negative pregnancy test at screening and must agree to use effective contraception throughout the duration of the study. If a subject becomes pregnant during the study, she will be discontinued immediately, and appropriate follow-up procedures will be initiated to ensure safety.
2. Subjects with Type 1 Diabetes Mellitus will be excluded due to the differing metabolic mechanisms and treatment goals from those with Type 2 Diabetes Mellitus T2DM.
3. Subjects with a history of major cardiovascular events, including myocardial infarction, stroke, unstable angina, or heart failure NYHA Class III or IV in the past 6 months, will be excluded. This ensures patient safety, as weight loss medications may have cardiovascular effects.
4. Individuals with uncontrolled hypertension systolic blood pressure more than 180 mmHg or diastolic blood pressure more than 100 mmHg will be excluded. Properly managed blood pressure is essential, as fluctuations may complicate the trial.
5. Those with a history of eating disorders, such as anorexia nervosa, bulimia, or binge-eating disorder, will be excluded, as participation in a weight loss trial may exacerbate disordered eating behaviours.
6. Subjects with significant liver or kidney dysfunction, such as cirrhosis or end-stage renal disease eGFR less than 30 mL per min per 1.73 meter square, will be excluded due to the potential risks of drug accumulation and impaired metabolism of Korglutide.
7. Subjects who have undergone bariatric surgery or are planning to undergo such surgery during the study will be excluded. Surgical interventions for weight loss could confound the trials outcomes.
8. Endocrine tumours Multiple endocrine neoplasia, type 2 MEN 2 or if someone in your family had these tumours.
9. Individuals who have used weightloss medications such as phentermine, orlistat, liraglutide or participated in structured weight loss programs within 3 months before screening will be excluded to ensure the effects observed are from Korglutide alone.
10. Subjects with a history of acute or chronic pancreatitis and Gallbladder diseases will be excluded. Certain weight loss drugs have been associated with an increased risk of pancreatitis, and this risk must be minimized.
11. Subjects with any active malignancy or a history of malignancy in the past 5 years except for adequately treated non melanoma skin cancer will be excluded. This is to avoid complicating factors from cancer treatments or the disease itself.
12. Subjects with severe psychiatric disorders such as major depression, schizophrenia, or active substance abuse will be excluded, as these conditions could interfere with adherence to the study protocol and accurate reporting of adverse effects.
13. Subjects who have taken any investigational drug or participated in another clinical trial within the past 30 days will be excluded. This prevents interference from other untested treatments.
14. Subjects with known hypersensitivity to Korglutide or any of its components will be excluded from the trial to prevent adverse reactions.
15. Individuals with chronic gastrointestinal conditions like Crohns disease, ulcerative colitis, or irritable bowel syndrome that could affect nutrient absorption or metabolism will be excluded, as these conditions may interfere with the outcomes.
16. Subjects with a recent history within 12 months of alcohol or drug abuse will be excluded. These conditions could compromise the subject’s ability to follow the study protocol or affect the study outcomes.
17. Individuals with severe hyperlipidaemia triglycerides more than 500 mg per dL that is uncontrolled by medication or diet will be excluded due to potential cardiovascular risks during the study.
18. Subjects who, in the investigators opinion, are unlikely to adhere to the study protocol e.g., non-compliance with treatment, frequent travel, or other significant life events will be excluded to maintain the integrity of the data collected.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Korglutide compared to placebo in inducing weight loss over a 12-week treatment period in obese individuals with and without Type 2 diabetes.  The primary efficacy endpoint will be the percent change in body weight from baseline to the end of the treatment period Baseline to Week 12. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of Subjects Achieving more than equal to 5 percent Weight Loss.  Week 12 
2. Proportion of Subjects Achieving more than 10 percent Weight Loss.  Week 12 
3. Change in Waist Circumference.  Baseline, Week 12 
4.Changes in HbA1c for Diabetic Cohort.  Baseline, Week 12 
5. Changes in Fasting Plasma Glucose.  Baseline, Week 12 
6. Changes in Lipid Profile   Baseline, Week 12 
7. Changes in Blood Pressure  Baseline, Week 12 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3 
Date of First Enrollment (India)   28/01/2025 
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 proposed study is a multi-centre, randomized, double-blind, placebo-controlled, parallelgroup clinical trial. The trial will enrol a total of 100 subjects, divided into two distinct cohorts.

The first cohort will consist of obese subject without a diagnosis of diabetes, while the second cohort will include obese individuals who have been diagnosed with Type 2 Diabetes Mellitus (T2DM). Each cohort will include 50 subjects, and both groups will receive either the investigational medicinal product, Korglutide, or a matching placebo.

The total duration of the study for each subject will be approximately 16 weeks. This will be divided into three main phases: a screening period lasting up to two weeks, a treatment period spanning 12 weeks, and a final follow-up period of two weeks after the treatment phase.

During the treatment phase, subjects will be administered Korglutide or placebo once daily. The drug will be provided in sachet form, dissolved in water, and consumed orally, as this is the intended method of administration for Korglutide. Subjects in the treatment group will receive the active drug, while those in the control group will receive a matching placebo that mimics the appearance and taste of Korglutide. The specific dosage will be determined based on prior studies,
with adjustments made to ensure both safety and efficacy in this patient population.

Randomization will occur on a 1:1 ratio, with half of the subjects in each cohort receiving Korglutide and the other half receiving placebo. Stratification will occur based on two key factors:
first, by cohort (obese individuals without diabetes vs. obese individuals with T2DM), and second, by baseline Body Mass Index (BMI), with subjects stratified into three categories—BMI of 30– 34.9 kg/m², BMI of 35–39.9 kg/m², and BMI of 40 kg/m² or greater.
 
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