NCT06937203招募中1 期
A Phase 1/2A Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity, defined as body mass index (BMI) between 30-50 kilograms (kg)/square meter (m^2), inclusive, with weight at Screening not to exceed 159 kg (350 pounds [lbs])
- •At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
- •No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results
- •Female participants of childbearing potential must agree to use highly effective contraception and male participants with female partners of childbearing potential must agree to use a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later
排除标准
- •Self-reported (or documented) weight gain or loss >5% within 3 months prior to Screening
- •Use of glucagon-like peptide-1 receptor agonist (GLP-1RAs) (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
- •Use of non-GLP-1R medications for weight loss within 3 months prior to Screening, including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate, and other prescription or over-the-counter medication or supplement taken for weight loss purposes
- •Obesity attributable primarily in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome)
- •History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures)
- •Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening
- •Type 1 diabetes mellitus
- •Note: Additional inclusion/exclusion criteria may apply per protocol.
研究组 & 干预措施
Part 1 and Part 2 (optional cohort): Placebo
Placebo Comparator
Placebo in single (Day 1) or multiple (Days 1 and 85) matching doses
干预措施: Placebo (Drug)
Part 2: Placebo + Tirzepatide
Placebo Comparator
Placebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253
干预措施: Placebo (Drug)
Part 1 and Part 2 (optional cohort): ARO-ALK7
Experimental
ARO-ALK7 in single (Day 1) or multiple (Days 1 and 85) ascending doses
干预措施: ARO-ALK7 (Drug)
Part:2: ARO-ALK7 + Tirzepatide
Experimental
ARO-ALK7 at ascending doses on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253
干预措施: ARO-ALK7 (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to Day 253 End of Study (EOS)
次要结局
- Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)(Through 48 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)(Through 48 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)(Through 48 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUC0-t)(Through 48 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-∞)(Through 48 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Terminal Elimination Half-life (t1/2)(Through 48 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Apparent Systemic Clearance (CL/F)(Through 48 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Apparent Terminal-phase Volume of Distribution (Vz/F)(Through 48 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after Dosing (Amount excreted: Ae)(Through 24 hours post-dose)
- PK of ARO-ALK7 (Part 1 Only): Fraction or Percentage of Administered Drug Excreted in Urine from Time 0 to 24 Hours after Dosing (Fe)(Through 24 hours post-dose)
- PK of ARO-ALK7: Renal Clearance (CLr)(Through 24 hours post-dose)
研究者
研究点 (16)
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