A 24-week Phase 2, Double-blind, Randomized, Placebo- Controlled, Single-center Safety and Efficacy Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO), and With a 24-week Open-label Extension, in Total 48 Weeks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety as Assessed by Liver and Kidney Function Tests
研究概览
简要总结
Double-blind, randomized, placebo-controlled, single- center study followed by an open-label extension period.
• The study will have two parts:
- Part 1: 24 weeks double-blind treatment (DB), followed by
- Part 2: 24 weeks open-label extension (OLE) - all subjects still participating at the end of Part 1 will be given an option to continue for additional 24 weeks on the active drug if evaluated eligible by the Investigator
详细描述
Part 1 - the double-blind (DB) part: The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks. The placebo arm will receive matching placebo tablets.
Part 2 - the open-label extension (OLE) part: All active participants at the end of the double-blind part will be given the active medication 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.
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
- •Informed consent obtained before any trial-related activities
- •Males and females, aged 18-75
- •Confirmed diagnosis of HIO
- •BMI ≥27 kg/m2 (where overweight is related to the HIO)
排除标准
- •Blood Pressure (BP) ≥160/90 mmHg
- •Heart rate (HR) ≥ 90, <50 bpm
- •Type 1 diabetes, Cushings disease, acromegaly, hypophysitis, infiltrative diseases or Prader-Willi syndrome
- •Heart failure New York Heart Association (NYHA) level II or greater, decompensated heart failure
- •Previous myocardial infarction or stroke within the last 5 years
研究组 & 干预措施
active arm
The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.
干预措施: Tesofensine/Metoprolol (Drug)
placebo arm
The placebo arm will receive matching placebo tesofensine and placebo metoprolol.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety as Assessed by Liver and Kidney Function Tests
时间窗: from Baseline to week 24
Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for gamma glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), glomerular filtration rate (GFR), and urea at baseline, week 12, and week 24 in each of the two treatment arms
Participants (Number and Percentage) With and Type of Serious Adverse Events
时间窗: from Baseline to week 24
Number and percentage of participants with at least one serious adverse event, indicating type, in each of the two treatment arms
Safety as Assessed by Diastolic Blood Pressure [mmHg]
时间窗: from Baseline to week 24
Diastolic blood pressure in mmHg measured at each visit in each of the two treatment arms
Number of Participants With Treatment Emergent Adverse Events
时间窗: from Baseline to week 24
Number and percentage of participants with adverse events in each of the two treatment arms
Safety as Assessed by Heart Rate [Bpm]
时间窗: from Baseline to week 24
Heart rate measured in beats per minute (bpm) at each visit in each of the two treatment arms
Safety as Assessed by Hematology Parameters
时间窗: from Baseline to week 24
Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for hemoglobin, platelet counts, white cells count, differential counts at baseline, week 12 and week 24 in each of the two treatment arms
Safety as Assessed by Electrolytes and Creatinine
时间窗: from Baseline to week 24
Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for sodium, potassium, creatinine at each visit in each of the two treatment arms
Number of Participants With at Least One Mild, Moderate or Severe Adverse Event
时间窗: from Baseline to week 24
Number and percentage of participants with mild, moderate or severe adverse events in each of the two treatment arms.
Safety as Assessed by Systolic Blood Pressure [mmHg]
时间窗: from Baseline to week 24
Systolic blood pressure in mmHg measured at each visit in each of the two treatment arms
次要结局
- Body Composition - Fat Mass(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Quality of Life - SF-36(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Blood Pressure (Change)(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- 24 Hours Blood Pressure(from baseline to week 12 and baseline to week 24)
- Plasma Trough Concentrations(baseline to week 48)
- Body Weight(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Body Composition - Lean Body Mass(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Lipid Profile(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Glycemic Control - HbA1c(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Thirst(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Number of Participants With Adverse Event(s) and/or Serious Adverse Event(s) - Open-label Extension(from week 24 to week 48)
- Heart Rate (Change)(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Waist Circumference(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Composite Satiety Score (CSS)(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Glycemic Control - Fasting Plasma Glucose(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- Craving for Something Sweet, Salty, Meat/Fish, or Fatty(from baseline to week 24, from baseline to week 48 and from week 24 to week 48)
- 48 Hours Heart Rate and QT Interval at Baseline, Week 12 and Week 24(baseline, week 12 and week 24)