A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide Plus a Reduced Calorie Diet and Increased Physical Activity in Participants With Obesity
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
- 试验地点
- 10
- 主要终点
- Assess the safety and tolerability of NT-0796 as an adjunct to semaglutide in participants with obesity by assessing AEs and SAEs, symptoms of nausea and vomiting, clinical laboratory parameters, vital signs and ECGs.
研究概览
简要总结
A Phase 2a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to explore the safety and efficacy of NT-0796 as an adjunct to semaglutide in participants with obesity over a 6 months treatment period.
详细描述
Potential participants will be screened within 28 days prior to baseline (Day 1), and eligible participants will be randomly assigned to receive the Investigational Medicinal Product (IMP, either NT-0796 or placebo) twice daily (BID). All participants will receive sc semaglutide. The IMP will be administered orally. Semaglutide will be initiated and titrated using a fixed, 4-weekly dose escalation scheme, as per the approved USPI.
Following 32 weeks of active treatment, participants will enter a 4-week safety follow-up period before being discharged from the study. Semaglutide will be provided for the period from baseline (Day 1) up until completion of the 4-week safety follow-up.
The Primary Endpoint of the study will be the safety and tolerability of NT-0796 as an adjunct to semaglutide, the key secondary endpoint will be the effect of NT-0796 as an adjunct to semaglutide on weight loss while secondary endpoints include percentage weight change from baseline.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female aged 18 to 75 years (inclusive) at Screening who have signed informed consent and are willing and able to comply with the study protocol.
- •Have a BMI of ≥30.0 kg/m2 and <45.0 kg/m2 at Screening. (BMI values should be calculated to one decimal point precision and then assessed in terms of the required range).
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
- •Meeting requirements for, and intending to start, treatment with sc semaglutide, as per the approved USPI.
排除标准
- •Exposure to incretins, irrespective of the indication, within the 12 months prior to Screening.
- •Known hypersensitivity to semaglutide or any of its excipients, or previous inability to tolerate semaglutide.
- •Type 1 or Type 2 Diabetes Mellitus (T1DM or T2DM), and/or HbA1c ≥6.5% (48 mmol/mol) at Screening and/or use of any anti-diabetic medications.
- •History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months prior to Day
- •History of acute coronary syndrome (ACS) including unstable angina, acute myocardial infarction (both ST segment elevation and non-ST segment elevation) within 6 months prior to Day 1.
研究组 & 干预措施
Placebo orally administered capsule
Participants will receive placebo twice daily orally for up to 32 weeks
干预措施: Placebo (Drug)
Twice daily orally administered NT-0796 capsule
Participants will receive study medication twice daily orally for up to 32 weeks, containing NT-0796 twice daily
干预措施: NT-0796 (Drug)
结局指标
主要结局
Assess the safety and tolerability of NT-0796 as an adjunct to semaglutide in participants with obesity by assessing AEs and SAEs, symptoms of nausea and vomiting, clinical laboratory parameters, vital signs and ECGs.
时间窗: Baseline to Week 24
次要结局
- Ratio change from baseline to Week 20 in hsCRP(Baseline to Week 20)
- Ratio change from baseline to Week 20 in Fibrinogen(Baseline to Week 20)
- Percent change in body weight in participants with obesity(Baseline to Week 20)
- Ratio change from baseline in hsCRP (mg/L)(Weeks 4, 8, 12, 16, 24, 28, 32 and 36)
- Time-averaged ratio change from baseline in hsCRP (mg/L)(Between weeks 4 and 32.)
- Time-to- achievement of hsCRP (mg/L) < 2, in the subset of subjects > 2 at baseline(Baseline to Week 32)
- Ratio change from baseline in fibrinogen (mg/dL)(Weeks 4, 8, 12, 16, 24, 28, 32 and 36)
- Percent change in body weight in participants with obesity(Baseline to Weeks 4, 8, 12, 16, 24, 28, 32, 36)
- Change in waist circumference and waist/height ratio(Baseline to Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36)
- Proportion of participants that achieve a body weight reduction of ≥5%, ≥10% or ≥15%(Baseline to Week 4, 8, 12, 16, 20, 24, 28, 32, 36)
- Proportion of participants that achieve a body weight reduction of ≥5%, ≥10% or ≥15%(Baseline to Week 20)
- NT-0796/NDT-19795 concentrations in plasma(Baseline to Week 24)
- Percent change in body weight in participants with obesity(Baseline to Weeks 4, 8, 12, 16, and 24)
- Change in waist circumference and waist/height ratio(Baseline to Weeks 4, 8, 12, 16, 20, and 24)