A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
8 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
300
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Backup dei contatti dello studio
- Nome: Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
- Numero di telefono: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Luoghi di studio
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Beijing, Cina, 100044
- Reclutamento
- Peking University People's Hospital
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Changchun, Cina, 130041
- Reclutamento
- The Second Hospital of Jilin University
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Hefei, Cina, 230601
- Reclutamento
- The Second Affiliated Hospital of Anhui Medical University
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Herbin, Cina, 150001
- Reclutamento
- The Fourth Affiliated Hospital of Harbin Medical University
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Huai'an, Cina
- Reclutamento
- Huai'an first people's hospital
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Huzhou, Cina, 313000
- Reclutamento
- Huzhou Central Hospital
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Jinan, Cina, 250013
- Reclutamento
- Jinan Central Hospital
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Langfang, Cina, 065000
- Reclutamento
- Hebei Petro China Central Hospital
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Luoyang, Cina, 471000
- Reclutamento
- Luoyang Third People's Hospital
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Nanjing, Cina, 211100
- Reclutamento
- The Affiliated Jiangning Hospital of Nanjing Medical University
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Shanghai, Cina, 200120
- Reclutamento
- Shanghai East Hospital
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Shanghai, Cina, 200072
- Reclutamento
- Shanghai Tenth People's Hospital
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Shanghai, Cina, 201304
- Reclutamento
- Shanghai Fifth People's Hospital affiliated to Fudan University
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Shanghai, Cina, 200336
- Reclutamento
- Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
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Shenyang, Cina, 110074
- Reclutamento
- Shenyang Fifth People Hospital
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Shenyang, Cina, 110016
- Reclutamento
- The People's Hospital of Liaoning Province
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Shijiazhuang, Cina, 050004
- Reclutamento
- Hebei Medical University - The Second Hospital
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Zibo, Cina, 255400
- Reclutamento
- Zibo Municipal Hospital.
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Henan
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Zhengzhou, Henan, Cina, 450014
- Reclutamento
- The Second Affiliated Hospital of Zhengzhou University
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Shaanxi
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Xianyang, Shaanxi, Cina, 712000
- Reclutamento
- Yan'an University Xianyang Hospital
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Zhejiang
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Ningbo, Zhejiang, Cina, 315010
- Reclutamento
- The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Placebo
I partecipanti riceveranno il placebo corrispondente.
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Participants will receive matching placebo via SC injection as per the schedule in the protocol.
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Percent Change From Baseline in Body Weight at Week 52
Lasso di tempo: Baseline through Week 52
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Baseline through Week 52
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At Week 52
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At Week 52
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Change From Baseline in Body Weight at Week 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Triglyceride at Week 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline through Week 52
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Baseline through Week 52
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Clinical Trials, Hoffmann-La Roche
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
3 luglio 2026
Completamento primario (Stimato)
24 febbraio 2028
Completamento dello studio (Stimato)
15 marzo 2028
Date di iscrizione allo studio
Primo inviato
22 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 giugno 2026
Primo Inserito (Effettivo)
26 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- YC46401
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .