2024-518086-99-00招募中4 期
Young adults with early-onset obesity treated with semaglutide -The RESETTLE study - a randomized double blind placebo-controlled clinical trial
Kobenhavns Universitet1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2024年10月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Primary endpoints (change from V1 to V2) Change in BMI (weight in kg/(height in m)2) from before to after GLP-1 RA compared to placebo.
研究概览
简要总结
A) To treat young adults with childhood-onset obesity, who have been resistant to structured lifestyle intervention (TCOC protocol), with the GLP-1 RA semaglutide 2.4mg for 68 weeks. B) To treat young adults with childhood-onset obesity, who have responded with insufficient weight loss to the structured lifestyle intervention (TCOC protocol) and remain obese, with the same GLP-1 RA, semaglutide 2.4mg for 68 weeks. C) To identify underlying mechanisms of lifestyle-untreatable versus treatable childhood-onset obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Young adults with early-onset obesity treated with semaglutide -The RESETTLE study - a randomized d
- 盲法
- Double (Subject, Carer, Investigator, Analyst)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18-28 years
- •The period from the initial treatment with TCOC protocol until inclusion in the study must be within 15 years.
- •Group A: BMI≥
- •Non-responders: No BMI SDS reduction (<0.1 BMI SDS) during TCOC protocol for more than one year and still have obesity (BMI≥30).
- •Group B: BMI≥
- •Insufficient responders: BMI SDS reduction >0.25 BMI SDS during TCOC protocol for more than one year, but still have obesity (BMI≥30).
- •Only baseline examination: Group C: BMI<
- •Excellent responders: BMI SDS reduction >0.5 BMI SDS during TCOC protocol for more than one year and no longer have obesity (BMI<30).
- •Only baseline examination: Group D: Young adults who have participated in The Holbaek Study and have had normal weight development during childhood.
排除标准
- •Participants diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l)
- •Use of medications causing clinically significant weight gain or loss
- •Previous bariatric surgery
- •A history of idiopathic acute pancreatitis
- •A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
- •Pregnancy, expecting pregnancy or breastfeeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Women with reproductive potential who are not using adequate contraceptive methods (combined oral contraceptive pill, progestin-only contraceptive pill, condoms, intrauterine device, injection, implant, or sterilization). Adequate contraception must be used throughout the study period and at least 2 months after discontinuation of trial medication (semaglutide will be present in the circulation for 5-7 weeks after the last dose).
- •Allergy to any of the ingredients/excipients of the study medication: semaglutide, disodium hydrogen phosphate dihydrate, hydrogen chloride, sodium chloride, sodium hydroxide and water for injection.
- •Exclusion criteria for MRI: e.g., pacemaker, claustrophobia, etc.
- •Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
- •Severe renal impairment (creatinine clearance (GFR) <30 mL/min)
- •Severe hepatic impairment
- •Inflammatory bowel disease
- •Diabetic gastroparesis
- •Chronic obstructive lung disease
- •Severe psychiatric disease, a history of major depressive or other serious psychiatric disorders
结局指标
主要结局
Primary endpoints (change from V1 to V2) Change in BMI (weight in kg/(height in m)2) from before to after GLP-1 RA compared to placebo.
Primary endpoints (change from V1 to V2) Change in BMI (weight in kg/(height in m)2) from before to after GLP-1 RA compared to placebo.
次要结局
- Secondary endpoints (change from V1 to V2) 1) Body composition 2) Body weight change 3) Participants with a reduction in body weight of at least 5%, 10%, 15%, and 20%
研究者
Signe Torekov
Scientific
Kobenhavns Universitet
研究点 (1)
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