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A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

8 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

300

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Copia de seguridad de contactos de estudio

  • Nombre: Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
  • Número de teléfono: 888-662-6728 (U.S. Only)
  • Correo electrónico: global-roche-genentech-trials@gene.com

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana, 100044
        • Reclutamiento
        • Peking University People's Hospital
      • Changchun, Porcelana, 130041
        • Reclutamiento
        • The Second Hospital of Jilin University
      • Hefei, Porcelana, 230601
        • Reclutamiento
        • The Second Affiliated Hospital of Anhui Medical University
      • Herbin, Porcelana, 150001
        • Reclutamiento
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Huai'an, Porcelana
        • Reclutamiento
        • Huai'an first people's hospital
      • Huzhou, Porcelana, 313000
        • Reclutamiento
        • Huzhou Central Hospital
      • Jinan, Porcelana, 250013
        • Reclutamiento
        • Jinan Central Hospital
      • Langfang, Porcelana, 065000
        • Reclutamiento
        • Hebei Petro China Central Hospital
      • Luoyang, Porcelana, 471000
        • Reclutamiento
        • Luoyang Third People's Hospital
      • Nanjing, Porcelana, 211100
        • Reclutamiento
        • The Affiliated Jiangning Hospital of Nanjing Medical University
      • Shanghai, Porcelana, 200120
        • Reclutamiento
        • Shanghai East Hospital
      • Shanghai, Porcelana, 200072
        • Reclutamiento
        • Shanghai Tenth People's Hospital
      • Shanghai, Porcelana, 201304
        • Reclutamiento
        • Shanghai Fifth People's Hospital affiliated to Fudan University
      • Shanghai, Porcelana, 200336
        • Reclutamiento
        • Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shenyang, Porcelana, 110074
        • Reclutamiento
        • Shenyang Fifth People Hospital
      • Shenyang, Porcelana, 110016
        • Reclutamiento
        • The People's Hospital of Liaoning Province
      • Shijiazhuang, Porcelana, 050004
        • Reclutamiento
        • Hebei Medical University - The Second Hospital
      • Zibo, Porcelana, 255400
        • Reclutamiento
        • Zibo Municipal Hospital.
    • Henan
      • Zhengzhou, Henan, Porcelana, 450014
        • Reclutamiento
        • The Second Affiliated Hospital of Zhengzhou University
    • Shaanxi
      • Xianyang, Shaanxi, Porcelana, 712000
        • Reclutamiento
        • Yan'an University Xianyang Hospital
    • Zhejiang
      • Ningbo, Zhejiang, Porcelana, 315010
        • Reclutamiento
        • The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Los participantes recibirán un placebo equivalente.
Producto combinado: Placebo
Participants will receive matching placebo via SC injection as per the schedule in the protocol.
Experimental: Enicepatide Dose 1
Participants will receive enicepatide Dose 1.
Producto combinado: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Otros nombres:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Enicepatide Dose 2
Participants will receive enicepatide Dose 2.
Producto combinado: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Otros nombres:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Enicepatide Dose 3
Participants will receive enicepatide Dose 3.
Producto combinado: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Otros nombres:
  • RO7795068
  • RG6640
  • CT-388

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Percent Change From Baseline in Body Weight at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
Periodo de tiempo: At Week 52
At Week 52
Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52
Periodo de tiempo: At Week 52
At Week 52
Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52
Periodo de tiempo: At Week 52
At Week 52
Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3
Periodo de tiempo: At Week 52
At Week 52
Change From Baseline in Body Weight at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist Circumference at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Fasting Glucose at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Fasting Insulin at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Triglyceride at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Systolic Blood Pressure at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
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
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
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
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist-to-Hip Ratio at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist-to-Height Ratio at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52
Periodo de tiempo: At Week 52
At Week 52
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
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Non-HDL Cholesterol at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Total Cholesterol at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Free Fatty Acids at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Diastolic Blood Pressure at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Serum Uric Acid at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Body Mass Index (BMI) at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Body Weight by Obesity Class at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in HbA1c at Week 52 in Participants With T2DM
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52
Periodo de tiempo: At Week 52
At Week 52
Change From Baseline in Total Lean Tissue Volume at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Total Lean Tissue Volume at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Total Adipose Tissue Volume at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Total Adipose Tissue Volume at Week 52
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria
Periodo de tiempo: Baseline to Safety Follow-Up (55 Weeks)
Baseline to Safety Follow-Up (55 Weeks)
Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score
Periodo de tiempo: Baseline through Week 52
Baseline through Week 52

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hoffmann-La Roche

Investigadores

  • Director de estudio: Clinical Trials, Hoffmann-La Roche

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

3 de julio de 2026

Finalización primaria (Estimado)

24 de febrero de 2028

Finalización del estudio (Estimado)

15 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de junio de 2026

Publicado por primera vez (Actual)

26 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • YC46401

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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