A Study to Evaluate the Safety and Efficacy of Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Safety and Efficacy of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
The aim of the study is to evaluate the safety and efficacy of oral ecnoglutide tablets in Chinese participants with overweight or obesity
調査の概要
詳細な説明
In this study, eligible participants will be randomized to one of the four cohorts to receive either oral ecnoglutide tablet or placebo for up to 24 weeks, including a dose escalation period.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Yao Li
- 電話番号:010-67889253
- メール:ra@sciwindbio.com
研究場所
-
-
Henan
-
Luoyang、Henan、中国
- The First Affiliated Hospital of Henan University of Science & Technology
-
コンタクト:
- Hongwei Jiang
- 電話番号:010-67889253
- メール:ra@sciwindbio.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- At the time of informed consent, BMI≥28.0 kg/m^2 regardless of comorbidities, or 24.0kg/m^2≤BMI<28.0 kg/m^2 with at least one of the comorbidities (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, weight-bearing joint pain, etc.);
- Self-declaration of body weight change <5% within 3 months prior to informed consent;
Exclusion Criteria:
- Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
- Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows C-TIRADS≥ class 4A), Medullary thyroid carcinoma, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
- Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, unstable angina, transient ischemic attack, acute stroke, acute coronary syndrome, congestive heart failure classified as New York Heart Association class III or IV, clinically significant arrhythmias requiring treatment, and cerebrovascular accidents, etc.
- Diagnosis of gastrointestinal diseases with clinical significance within 6 months prior to screening, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
- History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
- HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
- Clinical laboratory test results with clinical significance
研究計画
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:oral ecnoglutide dose 1
once daily from week1 to week 8, then once weekly from week 9 to week 24 |
oral tablet |
|
実験的:oral ecnoglutide dose 2
once daily from week1 to week 8, then once weekly from week 9 to week 24 |
oral tablet |
|
実験的:oral ecnoglutide dose 3
once daily from week1 to week 12, then once weekly from week 13 to week 24 |
oral tablet |
|
プラセボコンパレーター:Placebo
once daily from week1 to week 8 or week 12, then once weekly from week 9 or week 13 to week 24 |
oral tablet |
|
実験的:oral ecnoglutide dose 4
once daily from week1 to week 12, then once weekly from week 13 to week 24 |
oral tablet |
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 |
時間枠 |
|---|---|
|
Percentage Change in Body Weight
時間枠:Baseline, week 24
|
Baseline, week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants with ≥5% of Body Weight Loss
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Percentage of Participants with ≥10% of Body Weight Loss
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Percentage of Participants with ≥15% of Body Weight Loss
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Absolute Change in Body Weight
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Change in Body Mass Index (BMI)
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Change in blood pressure
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Change in other body measurements
時間枠:Baseline, week 24
|
Body measurements include neck circumference, waist circumference, hip circumference |
Baseline, week 24
|
|
Change in lipid profile
時間枠:Baseline, week 24
|
Include triglicerides, LDL-C, HDL-C, total cholesterol |
Baseline, week 24
|
|
Change in fasting blood glucose (FBG)
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Change in HbA1c
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Change in fasting insulin
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Change in blood uric acid
時間枠:Baseline, week 24
|
Baseline, week 24
|
|
|
Change in liver enzymes
時間枠:Baseline, week 24
|
include ALT and AST |
Baseline, week 24
|
|
Adverse events
時間枠:Week 1 to week 28 (EOS)
|
Week 1 to week 28 (EOS)
|
|
|
Plasma Concentration of Ecnoglutide
時間枠:Week 1 to week 28 (EOS)
|
Week 1 to week 28 (EOS)
|
協力者と研究者
捜査官
- 主任研究者:Hongwei Jiang、The First Affiliated Hospital of Henan University of Science and Technology
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。