NCT07497399招募中2 期
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study
Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年4月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in normalized (for head size) brain parenchymal volume (nBPV)
研究概览
简要总结
The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).
Researchers will compare outcomes from participants randomized to the study drug, versus participants randomized to placebo, to see if there are signs of slowed neurodegeneration (i.e., reduction in brain and retinal atrophy).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI
- •Aged 18-60 years
- •Body mass index ≥27.0 kg/m2
排除标准
- •No GLP-1RA or GIP/GLP-1 RA in past year; no known hypersensitivity to medication class
- •No known Barrett's esophagus/gastroesophageal reflux disease, pancreatitis (including past), or gastroparesis
- •No personal/family history of medullary thyroid carcinoma or history of multiple endocrine neoplasia syndrome type 2
- •No chronic kidney disease (estimated glomerular filtration rate ≤50 mL/min) in past year, type 1 diabetes, known diabetic retinopathy, use of insulin or insulin-inducing medications*, dipeptidyl peptidase IV inhibitors**, or warfarin; current/active alcohol or illicit substance abuse
- •No concerns about candidacy of individual on part of person's neurologist or study team clinicians
- •Current or planned (next 2 years) pregnancy/breastfeeding; if able to become pregnant, agree to reliable contraception (contraception requirements as discussed below)***
- •currently-approved: Lispro, Aspart, Glulisine, Afrezza, Regular, Concentrated Regular, or Novolin, Velosulin, NPH, glargine, detemir, degludec, and premixed; approved secretagogues: sulphonylureas (e.g. glipizide (± metformin), glyburide (± metformin), glimepiride, pioglitazone/glimepiride) & meglitinide analogues (nateglinide and repaglinide); ** currently-approved:sitagliptin, saxagliptin, linagliptin, alogliptin ***Contraception: Participants of childbearing potential (participant has a uterus and is pre-menopausal) must agree to use contraception, using either one method with a failure rate of <1%/year, or two methods of lesser effectiveness:
- •Contraceptive methods with a failure rate of < 1% per year includes the following:
- •Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or hormone-releasing implant), or copper IUD
- •Complete abstinence from sexual encounters with a person who has testes
- •Those who do not wish to use one of the above methods of contraception must use two methods. Options include:
- •Oral hormonal contraception plus one barrier method during sexual encounter with a person who has testes (below). While typically oral hormonal contraception has a low failure rate, it is possible that the absorption of contraceptive pills taken by mouth will be impacted by the study drug and thus lower contraceptive effectiveness. Thus, people using pills as primary contraception must, during asexual encounter with a person who has testes, use a second form of barrier contraceptive (below) or must change to one of the other contraceptive methods listed above.
- •Two forms of barrier contraception during sexual encounter with a person who has testes. Examples of barrier contraceptive methods include the following:
- •A condom with or without spermicide
- •A cap, diaphragm, or sponge with or without spermicide
- •Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
NLY01 (Study Drug)
Active Comparator
5 mg subcutaneous weekly for the first 4 weeks, then 10 mg subcutaneous weekly, with pre-planned dose adjustments if adverse events prevent full dosage.
干预措施: NLY01 (Drug)
结局指标
主要结局
Change in normalized (for head size) brain parenchymal volume (nBPV)
时间窗: Baseline, week 48, and week 96
Change in normalized (for head size) nBPV (mL). Measured from randomization to end of treatment (approximately 96 weeks). Presented as mean and standard deviation
次要结局
- Change in normalized gray matter volume (mL)(Baseline, week 48, and week 96)
- Change in thalamic volume (mL)(Baseline, week 48, and week 96)
- Change in cortical thickness (mm)(Baseline, week 48, and week 96)
- Change in retinal nerve fiber layer thickness(Baseline, week 48, and week 96)
- Change in ganglion cell/inner plexiform thickness(Baseline, week 48, and week 96)
- Disability progression as assessed by the Expanded Disability Status Scale (EDSS)(Approximately every 24 weeks, up to 96 weeks)
- Disability progression as assessed by the Multiple Sclerosis Functional Composite (MSFC)(Approximately every 24 weeks, up to 96 weeks)
- Disability progression as assessed by the Expanded Disability Status Scale-Plus(Approximately every 24 weeks, up to 96 weeks)
- Patient-reported disability progression as assessed by the Patient-Determined Disease Steps(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported anxiety as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Anxiety Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported depression as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Depression Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported fatigue as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Fatigue Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported upper extremity function as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Upper Extremity Function Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported lower extremity function as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Lower Extremity Function Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported cognitive function as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Cognitive Function Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in positive affect/well-being as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Positive Affect/Well-being Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported sleep disturbance as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Sleep Disturbance Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported ability to participate in social roles Quality of Life in Neurological Disorders (Neuro-QOL) Ability to Participate in Social Roles Subscale(Approximately every 24 weeks, up to 96 weeks)
- Change in self-reported stigma as assessed by the Quality of Life in Neurological Disorders (Neuro-QOL) Stigma Subscale(Approximately every 24 weeks, up to 96 weeks)
- Adverse events(From randomization to week 96)
- Serious adverse events(From randomization to week 96)
研究者
研究点 (2)
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