Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Korglutide Capsule 400mg: At any time of day, with or without meals to be consumed till 84 Days
Control Intervention1: Matching Placebo: At any time of day, with or without meals to be
Sponsors
Biosite Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females aged 18 to 75 years. 2.Body Mass Index (BMI) between 22 to 26 kg per m . 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.
Exclusion criteria
Exclusion criteria: 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 m ). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in bodyTimepoint: Baseline & Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in fat massTimepoint: Baseline & Day 84;Percent change in muscle massTimepoint: Baseline & Day 84;Percent change in fat percentageTimepoint: Baseline & Day 84;Percent change in waist hip ratio (WHR)Timepoint: Baseline & Day 84;Proportion of participants achieving greater than equal to 5% and less than equal to 10% total weight lossTimepoint: Baseline & Day 84;Percent change in visceral fat levelsTimepoint: Baseline & Day 84 | — |
Countries
India
Contacts
Public ContactDr Aditi Datta
Biosite Research Private Limited
Outcome results
None listed