NCT05832151已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 99
- 主要终点
- Effect of CIN-102 to significantly decrease gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores
研究概览
简要总结
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients.
The main questions it aims to answer are:
- To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo
- To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo
Participants will go through the following schedule:
-
Screening period (1-2 visits)
-
Lead-in period (1 visit)
-
Will complete a Gastric Emptying Breath Test (GEBT)
-
Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation
-
12-week treatment period (7 visits)
-
Study drug taken twice daily by mouth
-
Will complete daily diaries and other PROs as described in protocol
-
1 week follow-up (1 visit)
Researchers will compare the effects of the following treatments:
- Drug- CIN-102 Dose 15 mg or 10 mg
- Drug- Placebo
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a male or female ≥18 years of age;
- •Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;
- •Has a current diagnosis of diabetic gastroparesis defined by the following:
- •Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND
- •Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry.
- •Body mass index (BMI) between 18 and 49 kg/m2, inclusive;
- •Glycosylated hemoglobin (HbA1c) level <10% at Screening;
- •If receiving treatment with GLP-1RA, may be considered for the study if all of the following criteria are satisfied:
- •The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;
- •Has been on a stable dose of GLP-1RA for a minimum of 3 months before Screening and is anticipated to sustain the same dose during GEBT and throughout the study;
- •Is tolerating the GLP-1RA well based on Investigator's judgment;
- •None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
- •The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
- •Willing to washout from ongoing treatment for gastroparesis.
排除标准
- •Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesis and/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, or other neurologic disorder);
- •Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition;
- •History or evidence of clinically significant arrhythmia;
- •History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery;
- •Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression;
- •Pyloric injection of botulinum toxin within 6 months of Screening;
- •Positive test for drugs of abuse;
- •Has a known allergy to eggs or spirulina;
- •Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
研究组 & 干预措施
CIN-102: Dose 15mg or 10mg
Experimental
CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks
干预措施: CIN-102 Dose 15mg or 10mg (Drug)
Placebo
Placebo Comparator
Placebo for CIN-102, twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of CIN-102 to significantly decrease gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores
时间窗: Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale scores and the Vomiting subscale scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe)
次要结局
- Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline(Over the last 2 weeks of the 12-week Treatment Period as compared to baseline)
- Incidence of treatment emergent Serious Adverse Events (SAEs)(Over the 12-week Treatment Period)
- Incidence of treatment-emergent marked laboratory abnormalities.(Over the 12-week Treatment Period)
- Percentage of responders who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores(Over the last 2 weeks of the 12-week Treatment Period)
- The change in the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores among subjects receiving glucagon-like peptide-1 receptor agonist (GLP-1RA)(Over the 12-week Treatment Period as compared to baseline)
- The percentage of responders among subjects receiving GLP-1RA who demonstrate an average ≥0.5 reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores(Over the last 2 weeks of the 12-week Treatment Period)
- Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores(Over the last 2 weeks of the 12-week Treatment Period)
- Incidence of treatment-emergent adverse events (TEAEs)(Over the 12-week Treatment Period)
- Incidence of TEAEs leading to premature discontinuation of study drug(Over the 12-week Treatment Period)
- Change in the PGIC with each dose of CIN-102(From baseline to Week 12)
- The percentage of symptom-free days in the ANMS GCSI-DD Total Score, a composite of the Nausea Sub-Scale and Vomiting Scores, and Sub-Scale Scores(Over the last 2 weeks of the 12-week Treatment Period)
- The relationship between ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores and Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) over the 12-week Treatment Period;(Over the 12-week Treatment Period)
- Change in the PGIS with each dose of CIN-102(From baseline to Week 12)
- Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.(Over the 12-week Treatment Period)
- Percentage of subjects with a history of a lack of response or who could not tolerate metoclopramide therapy or other prokinetics, who demonstrate a >30% reduction from baseline on a composite score(Over the last 2 weeks of the 12-week Treatment Period as compared to baseline)
- The change in the ANMS GSCI-DD Total Score and a composite of gastroparesis-related symptoms among subjects receiving GLP-1RA;(over the last 2 weeks of the 12-week Treatment Period, as compared to baseline)
- All endpoints that are evaluated over the last 2 weeks of the 12-week Treatment period will also be evaluated over the last 6 weeks of the 12-week Treatment period.(Over the last 6 weeks of the 12-week Treatment Period)
- The percentage of subjects receiving GLP-1RA who achieve a ≥30% reduction from baseline on the ANMS GCSI-DD Nausea Sub-Scale and Vomiting Scores(Over the last 2 weeks of the 12-week Treatment Period)
研究者
研究点 (99)
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