Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
2026年5月1日 更新者：Wang Weiqing、Shanghai Jiao Tong University School of Medicine
A Single -Center, Randomized, Double-blind, Placebo-controlled Proof of Exploratory Study Evaluating the Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).
調査の概要
詳細な説明
This is an exploratory study to evaluate the efficacy, safety, and tolerability of CS0159 in combination with Semaglutide in MAFLD patients with obesity and T2DM.
Approximately 30 patients were randomly assigned to two groups in a 1:1 ratio for treatment for 12 weeks.
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yifei Zhang
- 電話番号：+86-13524640378
- メール：feifei-a@163.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 1. Age≥18 and ≤65 years, male or female.
- 2. MRI-PDFF ≥10% within 3 months prior to randomized.
- 3. Diagnosis of T2DM.
- 4. HbA1c: 7.0%-10.5%.
- 5. FPG: 7.0-13.3 mmol/L.
- 6. BMI: 30-45 kg/m2.
- 7. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period.
- 8. Willing to maintain consistent diet and exercise habits throughout the entire study, and adhere to the study protocol for timely administration of the study drug, and timely self-monitoring of blood glucose and recording.
- 9. Can understand the research content, follow the research protocol, and voluntarily sign the ICF.
Exclusion Criteria:
- 1. ALT≥2.5×ULN, AST≥2.5×ULN, TBil≥2×ULN, creatinine (Cr) ≥1.5×ULN and Serum creatinine clearance<60 mL/min, PLT<100×10^9/L, INR >1.3, ALB <3.5 g/dL.
- 2. Use of glucose-lowering medication in the 3 months prior to randomization.
- 3. Weight loss ≥ 5% in the 3 months prior to randomization or ≥10% in the 6 months prior to randomization or use of other weight-lowering drugs, corticosteroids, and etc.
- 4. History of allergy to glucagon-like peptide-1 receptor agonists (GLP-1RA) medications, currently in an allergic state, having allergic conditions, or history of allergies to ≥2 substances.
- 5. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.
- 6. Subjects with a history of severe pruritus.
- 7. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- 8. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.
- 9. History of acute or chronic pancreatitis.
- 10. Subjects with Child-Pugh class B or C grade cirrhosis.
- 11. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.
- 12. Arrhythmias, male QTc≥450 ms, or female QTc≥470 ms. Or cardiovascular disease for which the researcher has assessed that participation in the trial is not appropriate.
- 13. Diseases that interfere with the absorption, distribution, metabolism or excretion.
- 14. Gastrointestinal diseases that affect food digestion and absorption.
- 15. Use moderate or strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A4 enzyme) within the first 14 days of randomization and throughout the entire trial period.
- 16. History of malignant tumors within the first 5 years of randomization.
- 17. Serious hypoglycemic events occurring ≥ 3 times within 12 weeks prior to administration, or acute and severe metabolic disorder occurred within 12 weeks prior to administration.
- 18. Drug abuse or alcohol abuse within the first 6 months of randomization.
- 19. Poor blood pressure control.
- 20. Mental illness, epilepsy.
- 21. Patients with uncontrollable severe infectious diseases before randomization.
- 22. Pregnant, planned pregnancy or breastfeeding.
- 23. Participated in other clinical trials in the first three months of randomization.
- 24. Any condition that in the judgement of the researcher precludes participation.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：4mg CS0159
4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks
|
The intervention will include a 12-week treatment period.
During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).
The intervention will include a 12-week treatment period.
During the 12-week treatment period, subjects will receive 0.5mg Semaglutide (subcutaneous injection, once weekly).
|
|
プラセボコンパレーター：CS0159 Placebo
CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks
|
The intervention will include a 12-week treatment period.
During the 12-week treatment period, subjects will receive 0.5mg Semaglutide (subcutaneous injection, once weekly).
The intervention will include a 12-week treatment period.
During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage change in body weight relative to baseline
時間枠：Baseline to 12 weeks
|
Evaluate the percentage change in body weight relative to baseline after 12 weeks of treatment.
|
Baseline to 12 weeks
|
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Changes in energy expenditure
時間枠：Baseline to 12 weeks
|
The impact of the patient's energy expenditure change relative to the baseline after 12 weeks, assessed by whole-room indirect calorimetry (metabolic chamber).
|
Baseline to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in patient's weight relative to the baseline
時間枠：Baseline to 12 weeks
|
Evaluation of the change in patient's weight relative to the baseline after 12 weeks with CS0159
|
Baseline to 12 weeks
|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
時間枠：Baseline to 12 weeks
|
Evaluate the safety and tolerability of CS0159 combined with semaglutide during a 12-week treatment period
|
Baseline to 12 weeks
|
|
Change in patient's glucose oxidation
時間枠：Baseline to 12 weeks
|
Evaluation of the effect of CS0159 on glucose and lipid oxidation in patients relative to baseline after 12 weeks of administration, assessed by whole-room indirect calorimetry (metabolic chamber).
|
Baseline to 12 weeks
|
|
Change in patient's lipid oxidation
時間枠：Baseline to 12 weeks
|
Evaluation of the effect of CS0159 on glucose and lipid oxidation in patients relative to baseline after 12 weeks of administration, assessed by whole-room indirect calorimetry (metabolic chamber).
|
Baseline to 12 weeks
|
|
Percentage change in HbA1c relative to baseline
時間枠：Baseline to 12 weeks
|
Evaluate the percentage change in glycated hemoglobin (HbA1c) relative to baseline after 12 weeks of treatment.
|
Baseline to 12 weeks
|
|
Changes relative to baseline in BMI
時間枠：Baseline to 12 weeks
|
Changes in body mass index (BMI) relative to baseline after 12 weeks of administration
|
Baseline to 12 weeks
|
|
Changes relative to baseline in body composition
時間枠：Baseline to 12 weeks
|
Changes in body composition analysis relative to baseline after 12 weeks of administration
|
Baseline to 12 weeks
|
|
Changes relative to baseline in waist circumference
時間枠：Baseline to 12 weeks
|
Changes in waist circumference relative to baseline after 12 weeks of administration
|
Baseline to 12 weeks
|
|
Changes relative to baseline in waist to hip ratio (WHR)
時間枠：Baseline to 12 weeks
|
Changes in waist to hip ratio (WHR) relative to baseline after 12 weeks of administration
|
Baseline to 12 weeks
|
|
Changes relative to baseline in serum liver function parameters
時間枠：Baseline to 12 weeks
|
including alanine aminotransferase, aspartate aminotransferase, glutamyltransferase, alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin, total protein, albumin, and total bile acid.
|
Baseline to 12 weeks
|
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Changes relative to baseline in serum lipid profile
時間枠：Baseline to 12 weeks
|
including serum triglycerides, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol.
|
Baseline to 12 weeks
|
|
Changes relative to baseline in plasma glucose levels
時間枠：Baseline to 12 weeks
|
including fasting plasma glucose and 2-hour post-prandial plasma glucose
|
Baseline to 12 weeks
|
|
Changes relative to baseline in serum insulin levels
時間枠：Baseline to 12 weeks
|
including fasting serum insulin and 2-hour post-prandial serum insulin
|
Baseline to 12 weeks
|
|
Changes in peripheral blood metabolomics and proteomics relative to baseline
時間枠：Baseline to 12 weeks
|
Changes in peripheral blood metabolomics and proteomics relative to baseline after 12 weeks of administration
|
Baseline to 12 weeks
|
|
Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline
時間枠：Baseline to 12 weeks
|
Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline after 12 weeks of administration
|
Baseline to 12 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年11月30日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年3月15日
QC基準を満たした最初の提出物
2026年5月1日
最初の投稿 (実際)
2026年5月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月6日
QC基準を満たした最後の更新が送信されました
2026年5月1日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。