A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
8 septembre 2026 mis à jour par: Hoffmann-La Roche
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
300
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sauvegarde des contacts de l'étude
- Nom: Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
- Numéro de téléphone: 888-662-6728 (U.S. Only)
- E-mail: global-roche-genentech-trials@gene.com
Lieux d'étude
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Beijing, Chine, 100044
- Recrutement
- Peking University People's Hospital
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Changchun, Chine, 130041
- Recrutement
- The Second Hospital of Jilin University
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Hefei, Chine, 230601
- Recrutement
- The Second Affiliated Hospital of Anhui Medical University
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Herbin, Chine, 150001
- Recrutement
- The Fourth Affiliated Hospital of Harbin Medical University
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Huai'an, Chine
- Recrutement
- Huai'an first people's hospital
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Huzhou, Chine, 313000
- Recrutement
- Huzhou Central Hospital
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Jinan, Chine, 250013
- Recrutement
- Jinan Central Hospital
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Langfang, Chine, 065000
- Recrutement
- Hebei Petro China Central Hospital
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Luoyang, Chine, 471000
- Recrutement
- Luoyang Third People's Hospital
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Nanjing, Chine, 211100
- Recrutement
- The Affiliated Jiangning Hospital of Nanjing Medical University
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Shanghai, Chine, 200120
- Recrutement
- Shanghai East Hospital
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Shanghai, Chine, 200072
- Recrutement
- Shanghai Tenth People's Hospital
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Shanghai, Chine, 201304
- Recrutement
- Shanghai Fifth People's Hospital affiliated to Fudan University
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Shanghai, Chine, 200336
- Recrutement
- Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
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Shenyang, Chine, 110074
- Recrutement
- Shenyang Fifth People Hospital
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Shenyang, Chine, 110016
- Recrutement
- The People's Hospital of Liaoning Province
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Shijiazhuang, Chine, 050004
- Recrutement
- Hebei Medical University - The Second Hospital
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Zibo, Chine, 255400
- Recrutement
- Zibo Municipal Hospital.
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Henan
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Zhengzhou, Henan, Chine, 450014
- Recrutement
- The Second Affiliated Hospital of Zhengzhou University
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Shaanxi
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Xianyang, Shaanxi, Chine, 712000
- Recrutement
- Yan'an University Xianyang Hospital
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Zhejiang
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Ningbo, Zhejiang, Chine, 315010
- Recrutement
- The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m^2) for participants with type 2 diabetes mellitus (T2DM)
- BMI ≥28.0 kg/m^2 or BMI ≥24.0 and <28.0 kg/m^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
- Agreement to adhere to the contraception requirements
Exclusion Criteria:
- History of Type 1 diabetes mellitus (T1DM)
- Obesity induced by other endocrinologic disorders
- Any planned major medical procedure or surgery during the study
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
- Any lifetime history of suicide attempt
- History of any hematologic conditions that may interfere with HbA1c measurement
- History of acute or chronic pancreatitis or clinically significant gallbladder disease
- Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
- Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
- Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Placebo
Les participants recevront un placebo correspondant.
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Participants will receive matching placebo via SC injection as per the schedule in the protocol.
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Expérimental: Enicepatide Dose 1
Participants will receive enicepatide Dose 1.
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Autres noms:
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Expérimental: Enicepatide Dose 2
Participants will receive enicepatide Dose 2.
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Autres noms:
|
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Expérimental: Enicepatide Dose 3
Participants will receive enicepatide Dose 3.
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Percent Change From Baseline in Body Weight at Week 52
Délai: Baseline through Week 52
|
Baseline through Week 52
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
Délai: At Week 52
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At Week 52
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Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52
Délai: At Week 52
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At Week 52
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Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52
Délai: At Week 52
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At Week 52
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Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3
Délai: At Week 52
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At Week 52
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Change From Baseline in Body Weight at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Waist Circumference at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Fasting Glucose at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Fasting Insulin at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Triglyceride at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Systolic Blood Pressure at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in the Physical Functioning as Assessed by Short Form 36 Health Survey Acute, Version 2.0 (SF-36 v2 Acute) at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Physical Functioning Composite Score as Assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Waist-to-Hip Ratio at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Waist-to-Height Ratio at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52
Délai: At Week 52
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At Week 52
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Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Domain Scores and Component Summary Scores at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Non-HDL Cholesterol at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Total Cholesterol at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Free Fatty Acids at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Diastolic Blood Pressure at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Serum Uric Acid at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Body Mass Index (BMI) at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Percent Change From Baseline in Body Weight by Obesity Class at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in HbA1c at Week 52 in Participants With T2DM
Délai: Baseline through Week 52
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Baseline through Week 52
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Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52
Délai: At Week 52
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At Week 52
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Change From Baseline in Total Lean Tissue Volume at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Percent Change From Baseline in Total Lean Tissue Volume at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Total Adipose Tissue Volume at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Percent Change From Baseline in Total Adipose Tissue Volume at Week 52
Délai: Baseline through Week 52
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Baseline through Week 52
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Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria
Délai: Baseline to Safety Follow-Up (55 Weeks)
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Baseline to Safety Follow-Up (55 Weeks)
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Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Délai: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score
Délai: Baseline through Week 52
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Baseline through Week 52
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Trials, Hoffmann-La Roche
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
3 juillet 2026
Achèvement primaire (Estimé)
24 février 2028
Achèvement de l'étude (Estimé)
15 mars 2028
Dates d'inscription aux études
Première soumission
22 juin 2026
Première soumission répondant aux critères de contrôle qualité
22 juin 2026
Première publication (Réel)
26 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- YC46401
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .