A Multicenter, Randomized, Comparative, Active-Controlled, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety and Immunogenicity of Semaglutide injection in Weight Management
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 40
- 主要终点
- Percentage change in body weight
研究概览
简要总结
This is a randomized, multi-centric, open-label, active-controlled, parallel, comparative, phase III study. The study will be conducted in approximately up to 20 centres from various parts of India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval.
After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment (Appendix I). The total duration of the screening period will be of maximum 2 weeks (14 days). Patients will be issued a diary to record information about their meal, adverse events and medications during the screening period. Eligible patients will be randomized in 2:1 ratio to receive Sun’s Semaglutide (Test product) or Wegovy (Comparator product) respectively. Patients will receive total 24 doses of the study drug (either test or reference according to randomization) from week 0 till week 23. The study drug will be administered as weekly subcutaneous injection in abdomen, thigh or upper arm.
The doses of the study drug will be started at 0.25 mg and escalated to receive 2.4 mg at week 16 (Escalation phase). From week 16 to week 23 patients will receive the study drug at a dose of 2.4 mg (Maintenance phase). Patients will self-administer the drug at home. Patients will visit the site every 4 weeks. On the day of site visit patient can be administered the study drug at site and also counselled and trained on study drug administration at home. Patients will also be required to follow dietary restriction during the study as advised by a dietician. Patients will also be required to record details about study drug administration, concomitant medications and adverse events in the diary. Patients will be required to bring the completed diary at each visit. Patients will also be required to record details about study drug administration, concomitant medications and adverse events in the diary. Patients will be required to bring the completed diary at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria for all patients:
- •Male or female, aged 18 to 65 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia or type 2 diabetes mellitus (T2DM) at screening and randomization
- •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) Inclusion Criteria applicable for Type 2 Diabetes Mellitus patients:
- •Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
- •Subjects who are on a stable treatment with metformin, sulphonylurea (SU) or metformin + SU for at least 90 days before screening along with diet and exercise control.
排除标准
- •Exclusion Criteria for all patients:
- •Treatment with a GLP-1 receptor agonist within 180 days before screening
- •Treatment with Semaglutide previously
- •A self-reported change in body weight greater than 5 kg within 90 days before screening irrespective of medical records
- •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 greater than 1 year before screening, • lap banding, if the band has been removed greater than 1 year before screening, • intragastric balloon, if the balloon has been removed greater than 1 year before screening or • duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year before screening
- •History of OR presence of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder etc.)
- •History of Suicidal behaviour or suicidal ideation within 30 days before screening
- •Calcitonin greater than or equal to 100 ng/L at screening
- •Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR lesser than 30ml/min/1.73m2 [Note: eGFR will be calculated using MDRD formula]
- •Patients with aspartate transaminase [AST] greater than 2 x upper limit of normal [ULN] OR alanine transaminase [ALT] greater than 2 x ULN OR alkaline phosphatase [ALP] greater than 2 x ULN OR serum bilirubin greater than 1.5 x ULN) at Screening
- •Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
- •Known or suspected abuse of alcohol or recreational drugs
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Participation in another clinical trial within 90 days before screening
- •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
- •Any disorder, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol Exclusion criteria for Non -Diabetic Patients:
- •HbA1c greater than or equal to 6.5% as measured at screening Exclusion criteria for Diabetic Patients:
- •Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 90 days prior day of screening.
结局指标
主要结局
Percentage change in body weight
时间窗: From Baseline to week 24
次要结局
- Percentage change in body weight (For all patients)(From baseline to week 4, 8, 12, 16 and 20)
- Proportion of patients having body weight reduction greater than or equal to 5% (For all patients)(From baseline at week 4, 8, 12, 16, 20 and 24)
- Proportion of patients having body weight reduction greater than or equal to 10 % (For all patients)(From baseline at week 4, 8,12, 16, 20 and 24)
- Change in BMI (For all patients)(From baseline to week 4, 8, 12, 16, 20 and 24)
- Change in waist circumference (For all patients)(From baseline to week 4, 8, 12, 16, 20 and 24)
- Change in SF-36 total score (For all patients)(From baseline to week 4, 8, 12, 16, 20 and 24)
- Change in glycosylated hemoglobin (For Diabetic patients only)(From baseline to week 12 and 24)
- Change in FBG (For Diabetic patients only)(From baseline to week 4, 8, 12, 16, 20 and 24)
- Change in PPBG (For Diabetic patients only)(From baseline to week 4, 8, 12, 16, 20 and 24)
- Change in glycosylated hemoglobin (For Non-diabetic patients only)(From baseline to week 24)
- Change in FBG (For Non-diabetic patients only)(From baseline to week 24)
- Change in PPBG (For Non-diabetic patients only)(From baseline to week 24)
- Treatment Emergent Adverse Events (TEAEs)(Throughout the study period)
- Proportion of patients with anti-drug antibody (ADA) and Neutralising antibody (Nab) positive(Baseline and at week 24)
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited