CTRI/2021/10/037678进行中（未招募）2 期
Efficacy and safety investigation of NNC0194-0499 co-administered withsemaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging,placebo-controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Novo Nordisk
- 入组人数
- 672
- 试验地点
- 18
- 主要终点
- Improvement in liver fibrosis and no worsening of
研究概览
简要总结
Currently, no drugs are globally approved for the treatment of non-alcoholic steatohepatitis (NASH). First-line of treatment is lifestyle intervention to achieve weight loss and treatment of comorbidities (e.g. hyperlipidaemia, hypertension and diabetes). There is a substantial unmet medical need for effective treatments in patients with NASH. Combination treatment with modalities directed against multiple targets may result in better efficacy in subjects with NASH. This phase 2 trial will assess the safety and efficacy of three doses of NNC0194-0499 in combination with semaglutide versus placebo in the treatment of NASH. The trial will also include treatment arms for NNC0194-0499 alone, semaglutide alone and NNC0174-0833 in combination with semaglutide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects are eligible to be included in the trial only if all of the following criteria apply:
- •Informed consent obtained before any trial-related activities.
- •Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Aged ≥ 18 years at the time of signing informed consent.
- •Japan, Republic of Korea and Singapore: Please see local requirements in Appendix 9 (Section 10.9).
- •Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy.
- •The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to V
- •Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.
- •Histological NAFLD activity score (NAS) ≥ 4 for subjects with F2/F3 or ≥ 3 for subjects with F4 based on a central pathologist evaluation of the baseline liver biopsy.
- •All subjects must have a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.
排除标准
- •â€¢ Documented causes of chronic liver disease other than NAFLD.
- •â€¢ Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
- •â€¢ Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at V2A.
- •â€¢ Presence or history of gastro-oesophageal varices ≥ grade 2 at V2A.
- •For subjects with F4, an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2A must be available at V2A.
- •â€¢ Known or suspected excessive consumption of alcohol (> 20 g/day for women or > 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
- •â€¢ Treatment with vitamin E (at doses ≥ 800 IU/day) or pioglitazone or medications approved for the treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to V2A.
- •In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
- •â€¢ Treatment with GLP-1 RAs within 90 days prior to V2A.
- •Subjects with a historical liver biopsy taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs from time of biopsy until V2A.
- •â€¢ Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to V2A.
结局指标
主要结局
Improvement in liver fibrosis and no worsening of
时间窗: Week 0 to Week 52
NASH
时间窗: Week 0 to Week 52
次要结局
- Resolution of steatohepatitis and no worsening of liver(fibrosis)
研究者
研究点 (18)
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