A Double-Blind, Randomized, Multi-Center, Dose-Ranging, Phase 2 Study of the Efficacy and Safety of ALV-100 Versus Placebo for Maintenance of Weight Loss in Patients Previously on Semaglutide
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 12
- 主要终点
- Dose response of ALV-100 as assessed by maintenance of weight loss
研究概览
简要总结
A study of ALV-100 to assess efficacy, safety and tolerability among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with semaglutide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female participants, aged ≥18 to ≤75
- •BMI ≥27 kg/m2 at screening.
- •Has been treated with semaglutide for weight management at a stable dose for at least 3 continuous months prior to screening.
- •Tolerating semaglutide at the discretion of the investigator
- •WL of at least 10% while on semaglutide and with stable BW for at least 3 months prior to screening.
- •Willing to maintain their current general diet and physical activity regimen throughout the study.
排除标准
- •Lifetime history of Type 1 or Type 2 diabetes
- •Prior obesity treatment with surgery or a weight loss device.
- •Obesity caused by known endocrinologic disorders or by known congenital or acquired hypothalamic disease or monogenetic or syndromic forms of obesity.
- •Current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain.
- •Family or personal history of MTC or MEN 2
- •Presence or history of malignant neoplasms within the past 5 years prior to screening
研究组 & 干预措施
Dose A - Schedule 1
Participants will receive ALV-100 or volume matched placebo during the treatment period
干预措施: ALV-100 (Drug)
Dose A - Schedule 1
Participants will receive ALV-100 or volume matched placebo during the treatment period
干预措施: Placebo (Drug)
Dose B - Schedule 1
Participants will receive ALV-100 or volume matched placebo during the treatment period
干预措施: ALV-100 (Drug)
Dose B - Schedule 1
Participants will receive ALV-100 or volume matched placebo during the treatment period
干预措施: Placebo (Drug)
Dose C - Schedule 1
Participants will receive ALV-100 or volume matched placebo during the treatment period
干预措施: ALV-100 (Drug)
Dose C - Schedule 1
Participants will receive ALV-100 or volume matched placebo during the treatment period
干预措施: Placebo (Drug)
Dose A - Schedule 2
Participants will receive ALV-100 or volume matched placebo during the treatment period
干预措施: ALV-100 (Drug)
Dose A - Schedule 2
Participants will receive ALV-100 or volume matched placebo during the treatment period
干预措施: Placebo (Drug)
结局指标
主要结局
Dose response of ALV-100 as assessed by maintenance of weight loss
时间窗: 24 weeks
Percentage change from baseline to Week 24 in BW
次要结局
- Assess the safety and tolerability of ALV-100(36 weeks)
- Efficacy of ALV-100 compared to placebo as assessed by maintenance of weight loss(24-36 weeks)
- Change from baseline in glycemic control parameters(24-36 weeks)
- Change from baseline in lipid parameters(24-36 weeks)
- Change from baseline in vital signs(24-36 weeks)
- Immunogenicity of ALV-100(36 weeks)
- Efficacy of ALV-100 versus placebo on subjective control of eating, food cravings, and mood-related eating behaviors as assessed by the Control of Eating Questionnaire (CoEQ)(24-36 weeks)
- Effect of ALV-100 vs. placebo on food noise as assessed by the Food Noise Questionnaire (FNQ)(24-36 weeks)