CTRI/2025/07/090921进行中（未招募）3 期
A Multicenter, Randomized, Comparative, Active-Controlled, Open-Label, Phase III Study to evaluate the Efficacy and Safety of Semaglutide Injection In Comparison With Wegovy® (Semaglutide) Injection in Weight Management.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 258
- 试验地点
- 18
- 主要终点
- Percentage change in body weight
研究概览
简要总结
Obesity and overweight are conditions that increase the risk of chronic health outcomes, including hypertension, dyslipidemia, type 2 diabetes, cardiovascular disease, and certain cancers. Weight loss of 5-10 percent in patients through diet and exercise is generally accepted as beneficial on cardiometabolic risk factors.
Standard-of-care for treatment is lifestyle therapy, such as reduced calorie, nutritionally complete diets, increased physical activity, and behavioural modification but the magnitude of weight loss achieved can be limited and difficult to maintain. Patients with morbid obesity can have good outcomes with bariatric surgery. However, surgical therapies are limited by factors including adverse effects, cost, and insurance coverage, and there remains an unmet medical need. Semaglutide injection has already been approve by FDA for management of obesity. It has been found effective in weight management in phase III trial. The weight-loss benefit of semaglutide outweighs the potential risks in the intended population. The treatment effect on weight loss is clinically meaningful and expected to improve health outcomes in patients with obesity and overweight.
Natco Pharma Limited has developed a proposed biosimilar to semaglutide Injection, and intends to conduct a phase III clinical study in India. It is comparable to the RMP in terms of its physicochemical characteristics, structure, and mechanism of action. Taking into account the results of the analytical similarity, pharmacological, and toxicological profiles of IMP, and previous clinical and marketing experience of WEGOVY, the present study has been planned to compare the efficacy and safety of IMP versus Reference Biologic WEGOVY in Weight Management.
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
- •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).
- •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.
排除标准
- •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.
- •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.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 jeopardize the subject’s safety or compliance with the protocol.
- •28.Treatment with glucose-lowering agent(s) within 90 days before screening.
- •Exclusion criteria for Diabetic Patients: 29.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: Baseline and Week 24
次要结局
- Change in BMI(Baseline, Weeks 4, 8, 12, 16, 20 and 24)
- Change in waist circumference from baseline(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Change in SF-36 total score from baseline(Baseline, Weeks 4, 8, 12, 16, 20 and 24)
- Percentage change in body weight(Baseline, Weeks 4, 8, 12, 16 and 20)
- Proportion of patients having body weight reduction more than or equal to 5 percent from baseline(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Proportion of patients having body weight reduction more than or equal to 10 percent from baseline(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- For Diabetic patients only: Change in glycosylated hemoglobin from baseline(Baseline, Weeks 12 and 24)
- For Diabetic patients only: Change in FBG from baseline(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- For Diabetic patients only: Change in PPBG from baseline(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- For Non-diabetic patients only: Change in FBG from baseline(Baseline, Week 24)
- For Non-diabetic patients only:Change in glycosylated hemoglobin from baseline(Baseline, Week 24)
- For Non-diabetic patients only: Change in PPBG from baseline(Baseline, Week 24)
研究者
Mr Kartik Sahni
Insignia Clinical Services Pvt. Ltd.
研究点 (18)
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