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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 setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

300

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

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

Estude backup de contato

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

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Os participantes receberão placebo correspondente.
Produto 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.
Produto combinado: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Outros nomes:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Enicepatide Dose 2
Participants will receive enicepatide Dose 2.
Produto combinado: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Outros nomes:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Enicepatide Dose 3
Participants will receive enicepatide Dose 3.
Produto combinado: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Outros nomes:
  • RO7795068
  • RG6640
  • CT-388

O que o estudo está medindo?

Medidas de resultados primários

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

Medidas de resultados secundários

Medida de resultado
Prazo
Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
Prazo: At Week 52
At Week 52
Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52
Prazo: At Week 52
At Week 52
Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52
Prazo: At Week 52
At Week 52
Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3
Prazo: At Week 52
At Week 52
Change From Baseline in Body Weight at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist Circumference at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Fasting Glucose at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Fasting Insulin at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Triglyceride at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Systolic Blood Pressure at Week 52
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist-to-Hip Ratio at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist-to-Height Ratio at Week 52
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Non-HDL Cholesterol at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Total Cholesterol at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Free Fatty Acids at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Diastolic Blood Pressure at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Serum Uric Acid at Week 52
Prazo: 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
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Body Mass Index (BMI) at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Body Weight by Obesity Class at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in HbA1c at Week 52 in Participants With T2DM
Prazo: 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
Prazo: At Week 52
At Week 52
Change From Baseline in Total Lean Tissue Volume at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Total Lean Tissue Volume at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Total Adipose Tissue Volume at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Total Adipose Tissue Volume at Week 52
Prazo: Baseline through Week 52
Baseline through Week 52
Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria
Prazo: 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
Prazo: Baseline through Week 52
Baseline through Week 52
Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score
Prazo: Baseline through Week 52
Baseline through Week 52

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Investigadores

  • Diretor de estudo: Clinical Trials, Hoffmann-La Roche

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de julho de 2026

Conclusão Primária (Estimado)

24 de fevereiro de 2028

Conclusão do estudo (Estimado)

15 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

22 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de junho de 2026

Primeira postagem (Real)

26 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • YC46401

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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