- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07929298
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yao Li
- Numéro de téléphone: 010-67889253
- E-mail: ra@sciwindbio.com
Lieux d'étude
-
-
Henan
-
Luoyang, Henan, Chine
- The First Affiliated Hospital of Henan University of Science & Technology
-
Contact:
- Hongwei Jiang
- Numéro de téléphone: 010-67889253
- E-mail: ra@sciwindbio.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: oral ecnoglutide dose 1
once daily from week1 to week 8, then once weekly from week 9 to week 24 |
oral tablet |
|
Expérimental: oral ecnoglutide dose 2
once daily from week1 to week 8, then once weekly from week 9 to week 24 |
oral tablet |
|
Expérimental: oral ecnoglutide dose 3
once daily from week1 to week 12, then once weekly from week 13 to week 24 |
oral tablet |
|
Comparateur placebo: 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 |
|
Expérimental: oral ecnoglutide dose 4
once daily from week1 to week 12, then once weekly from week 13 to week 24 |
oral tablet |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Percentage Change in Body Weight
Délai: Baseline, week 24
|
Baseline, week 24
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants with ≥5% of Body Weight Loss
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Percentage of Participants with ≥10% of Body Weight Loss
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Percentage of Participants with ≥15% of Body Weight Loss
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Absolute Change in Body Weight
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in Body Mass Index (BMI)
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in blood pressure
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in other body measurements
Délai: Baseline, week 24
|
Body measurements include neck circumference, waist circumference, hip circumference |
Baseline, week 24
|
|
Change in lipid profile
Délai: Baseline, week 24
|
Include triglicerides, LDL-C, HDL-C, total cholesterol |
Baseline, week 24
|
|
Change in fasting blood glucose (FBG)
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in HbA1c
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in fasting insulin
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in blood uric acid
Délai: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in liver enzymes
Délai: Baseline, week 24
|
include ALT and AST |
Baseline, week 24
|
|
Adverse events
Délai: Week 1 to week 28 (EOS)
|
Week 1 to week 28 (EOS)
|
|
|
Plasma Concentration of Ecnoglutide
Délai: Week 1 to week 28 (EOS)
|
Week 1 to week 28 (EOS)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hongwei Jiang, The First Affiliated Hospital of Henan University of Science and Technology
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SCW0503-1121
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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