| CTRI Number |
CTRI/2025/08/092392 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to evaluated the Effectiveness of Korglutide in Weight Management in Non-Diabetic Individuals with Elevated Body Fat and Normal to Overweight BMI. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy and Safety of Korglutide in Weight Management in Non-Diabetic Individuals with Elevated Body Fat and Normal Overweight BMI. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSR/CT/013/28 Version: 1.0 Date 13 May 2025 |
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 |
3rd Floor 36 37 Phoenix 5 Kothnur Main Road Santhrupthi Nagar JP Nagar Phase 7 Bengaluru
Bangalore
KARNATAKA
560078
India |
| Phone |
9811788955 |
| 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 |
3rd Floor 36 37 Phoenix 5 Kothnur Main Road Santhrupthi Nagar JP Nagar Phase 7 Bengaluru
KARNATAKA
560078
India |
| Phone |
9811788955 |
| 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 |
3rd Floor 36 37 Phoenix 5 Kothnur Main Road Santhrupthi Nagar JP Nagar Phase 7 Bengaluru
KARNATAKA
560078
India |
| Phone |
9811788955 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
|
Source of Monetary or Material Support
|
| Biosite Research Private Limited |
|
|
Primary Sponsor
|
| Name |
Biosite Research Private Limited |
| Address |
3rd Floor 36 37 Phoenix 5 Kothnur Main Road Santhrupthi Nagar JP Nagar Phase 7 Bengaluru |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Utsa Basu |
Dr Utsa Basu Clinic |
Room no 6 65A middle Road Philips More 14 Entally Kolkata 700014
Kolkata
WEST BENGAL |
9432658968
dr.utsabasu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Korglutide Capsule 400mg |
At any time of day, with or without meals to be consumed till 84 Days |
| Comparator Agent |
Matching Placebo |
At any time of day, with or without meals to be consumed till 84 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females aged 18 to 75 years.
2.Body Mass Index (BMI) between 22 to 26 kg per m².
3.High body fat percentage, defined as less than and equal to 25 percent for males and less than and equal to 28 percnt for females.
4.Stable weight (plus minus 3 kg fluctuation) for at least 3 months prior to screening.
5.Fasting plasma glucose (FPG) less than 126 mg per dL and HbA1c less than 6.5 percent to confirm non-diabetic status.
6.Willingness to comply with the prescribed dietary and physical activity recommendations.
7.Non-smoker.
8.Vital signs are normal or deemed abnormal but 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 (diaphragm, cervical cap, or condom) plus a contraceptive jelly (spermicidal foam, gel, film, cream, or suppository). If the female sexual partner of the male is using an approved form of contraception (see inclusion criterion 10) 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 (absence of menses for 1 year or more), 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.
11.Subjects who can provide informed consent and complying with all study procedures/requirements.
|
|
| ExclusionCriteria |
| Details |
1. Participants diagnosed with Type 1 or Type 2 diabetes, metabolic syndrome, or other metabolic disorders that affect weight regulation.
2. Prior history of bariatric surgery or any weight-loss procedure within the last five years.
3.Cardiovascular conditions: History of myocardial infarction, stroke, heart failure (NYHA class II-IV), or uncontrolled hypertension (SBP greater than 160 mmHg or DBP greater than 100 mmHg).
4.Presence of hypothyroidism, hyperthyroidism, Cushing’s syndrome, or any other endocrine disorder that may interfere with metabolic function.
5.Liver and kidney dysfunction: Patients with AST/ALT levels greater than 3 times the upper limit of normal, chronic liver disease, cirrhosis, or chronic kidney disease (eGFR less than 60 mL per min per 1.73 m²).
6.Use of weight-modulating medications: Any use of GLP-1 receptor agonists, corticosteroids, anabolic steroids, appetite suppressants, or other weight-modulating agents within three months prior to screening.
7.Women who are pregnant, planning to become pregnant, or breastfeeding during the study.
8.Participants with a prior diagnosis of anorexia nervosa, bulimia nervosa, binge-eating disorder, or any other eating disorder.
9.Current or recent alcohol or drug abuse within the past 12 months.
10.Any history of cancer within the past five years, except for successfully treated non-melanoma skin cancer.
11.Participation in other clinical trials: Enrollment in another clinical trial within the past 90 days.
12.Presence of major depressive disorder, schizophrenia, bipolar disorder, or other psychiatric illnesses that may impair compliance.
13.Participants with a known allergy to Korglutide or any of its excipients.
14.History of gastroparesis, inflammatory bowel disease (Crohn’s disease, ulcerative colitis), or chronic pancreatitis.
15.Presence of severe peripheral neuropathy, epilepsy, or neurodegenerative diseases that may impact study compliance.
16.Patients with HIV, active hepatitis B or C, or tuberculosis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent change in body |
Baseline & Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percent change in fat mass |
Baseline & Day 84 |
| Percent change in muscle mass |
Baseline & Day 84 |
| Percent change in fat percentage |
Baseline & Day 84 |
| Percent change in waist hip ratio (WHR) |
Baseline & Day 84 |
| Proportion of participants achieving greater than equal to 5% and less than equal to 10% total weight loss |
Baseline & Day 84 |
| Percent change in visceral fat levels |
Baseline & Day 84 |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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)
|
14/08/2025 |
| 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="0"
Months="9"
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
|
This clinical trial is a randomized, double-blind, placebo-controlled study, conducted over an 84-day period with a follow-up phase on days 28 and 56. The primary focus is to evaluate the effects of Korglutide in non-diabetic patients (BMI 22–26 kg/m² with high body fat percentage). Participants will be randomized in a 2:1 ratio to receive either Korglutide or placebo. The study aims to measure not only weight loss but also fat mass reduction and muscle mass preservation, ensuring that Korglutide leads to effective fat reduction while maintaining muscle integrity. Baseline stratification by fat percentage levels will be implemented to reduce variability and improve statistical power. Body composition will be evaluated using bioelectrical impedance analysis (BIA), with assessments conducted at multiple time points.
The study encompasses four primary phases - Screening
- Randomization and Baseline
- Treatment,
- Follow-Up.
Each phase is crucial for ensuring the validity and reliability of outcomes, with detailed processes and assessments aligned with regulatory requirements. - Visit 1: Screening
- Visit 2: Baseline/Randomization (Day 0)
- Visit 3: Interim Assessment (Day 28)
- Visit 4: Interim Assessment (Day 56)
- Visit 5: End of Treatment (Day 84)
|