Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Semaglutide Injection 0.25mg, 0.5mg, 1mg, 1.7mg, 2.4mg: Test drug will be administered once weekly on the same day each week subcutaneously at any time of day, with or without meals for
Sponsors
Natco Pharma Limited
Natco Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study. 2.Body mass index (BMI) more than or equal to 30 kg per m2 or more than or equal 27 kg per m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated) hypertension, dyslipidemia or type 2 diabetes mellitus (T2DM) at screening and randomization. 3.History of at least one self-reported unsuccessful dietary effort to lose body weight. 4.Willing to comply with the dietary and physical activity requirement during the study. 5.Women of childbearing potential must have a negative urine pregnancy test prior to study entry. [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural(spontaneous) amenorrhea and be greater than 45 years of age] 6.Patients and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 2 months after end of treatment. (Note: Acceptable methods of contraception A. Male: Vasectomy, Condoms, Total abstinence; B. Females: hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total sexual abstinence) and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence). Addl. Inclusion Criteria applicable for Type 2 Diabetes Mellitus patients- 7.Diagnosed with T2D more than or equal to 180 days prior to the day of screening. 8.Subjects who are on a stable treatment with metformin, sulphonylureas (SU) or metformin + SU for at least 90 days before screening along with diet and exercise control. 9.HbA1c 7.0-10.0% (both inclusive) at screening.
Exclusion criteria
Exclusion criteria: 1.History of type 1 diabetes mellitus. 2.Treatment with a GLP-1 receptor agonist within 180 days before screening. 3.Treatment with Semaglutide previously. 4.A self-reported change in body weight more than 5 kg within 90 days before screening irrespective of medical records. 5.Treatment with any medication for the indication of obesity AND any medications affecting weight (other than oral contraceptives) within the past 90 days before screening. 6.Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed- Liposuction and or abdominoplasty, if performed more than 1 year before screening, Lap banding, if the band has been removed more than 1 year before screening, Intragastric balloon, if the balloon has been removed more than 1 year before screening or, Duodenal-jejunal bypass sleeve, if the sleeve has been removed more than 1 year before screening, 7.Uncontrolled thyroid disease, defined as TSH more than 6.0 mIU per L or less than 0.4 mIU per L. 8.History of major depressive disorder within 2 years before screening. 9.History of OR presence of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder etc.). 10.A lifetime history of a suicidal attempt. 11.History of Suicidal behaviour or suicidal ideation within 30 days before screening. 12.Patients having Hamilton Depression Rating Scale (HAM-D; 17 items) total score more than or equal to 10, and or a score of more than or equal to 2 on Suicide item of HAM-D; 17 items scale at Screening. 13.Use of any herbal, non-herbal medicine with unknown, unspecified content within 90 days before screening. 14.History or presence of pancreatitis. 15.Calcitonin more than or equal to 100 ng per L at screening. 16.Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. 17.Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30ml per min per 1.73m2 [Note- CrCl will be calculated using MDRD formula]. 18.Patients with aspartate transaminase [AST] more than 2 x upper limit of normal [ULN] OR alanine transaminase [ALT] more than 2 x ULN OR alkaline phosphatase [ALP] more than 2 x ULN OR serum bilirubin more than 1.5 x ULN) at Screening. 19.History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed. 20.History of myocardial infarction, stroke or hospitalisation for unstable angina or transient ischemic attack within the past 60 days prior to screening. 21.Presence of heart failure classified as being in New York Heart Association (NYHA) Class II, III and IV. 22.Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator. 23.Known or suspected abuse of alcohol or recreational drugs. 24.Known or suspected hypersensitivity to trial product(s) or related products. 24.Participation in another clinical trial within 90 days before screening. 25.Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. 26.Any disorder, which in the investigator s opinion, might jeop
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weightTimepoint: Baseline and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in body weightTimepoint: Baseline, Weeks 4, 8, 12, 16 and 20;Proportion of patients having body weight reduction more than or equal to 5 percent from baselineTimepoint: Baseline, Weeks 4, 8, 12, 16, 20, and 24;Proportion of patients having body weight reduction more than or equal to 10 percent from baselineTimepoint: Baseline, Weeks 4, 8, 12, 16, 20, and 24;Change in BMITimepoint: Baseline, Weeks 4, 8, 12, 16, 20 and 24;Change in waist circumference from baselineTimepoint: Baseline, Weeks 4, 8, 12, 16, 20, and 24;Change in SF-36 total score from baselineTimepoint: Baseline, Weeks 4, 8, 12, 16, 20 and 24;For Diabetic patients only: Change in glycosylated hemoglobin from baselineTimepoint: Baseline, Weeks 12 and 24;For Diabetic patients only: Change in FBG from baselineTimepoint: Baseline, Weeks 4, 8, 12, 16, 20, and 24;For Diabetic patients only: Change in PPBG from baselineTimepoint: Baseline, Weeks 4, 8, 12, 16, 20, and 24;For Non-diabetic patients only: Change in FBG from baselineTimepoint: Baseline, Week 24;For Non-diabetic patients only:Change in glycosylated hemoglobin from baselineTimepoint: Baseline, Week 24;For Non-diabetic patients only: Change in PPBG from baselineTimepoint: Baseline, Week 24 | — |
Countries
India
Contacts
Public ContactDr G Venkata Ramana
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed