A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
8 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
300
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studie Contact Back-up
- Naam: Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
- Telefoonnummer: 888-662-6728 (U.S. Only)
- E-mail: global-roche-genentech-trials@gene.com
Studie Locaties
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Beijing, China, 100044
- Werving
- Peking University People's Hospital
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Changchun, China, 130041
- Werving
- The Second Hospital of Jilin University
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Hefei, China, 230601
- Werving
- The Second Affiliated Hospital of Anhui Medical University
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Herbin, China, 150001
- Werving
- The Fourth Affiliated Hospital of Harbin Medical University
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Huai'an, China
- Werving
- Huai'an first people's hospital
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Huzhou, China, 313000
- Werving
- Huzhou Central Hospital
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Jinan, China, 250013
- Werving
- Jinan Central Hospital
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Langfang, China, 065000
- Werving
- Hebei Petro China Central Hospital
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Luoyang, China, 471000
- Werving
- Luoyang Third People's Hospital
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Nanjing, China, 211100
- Werving
- The Affiliated Jiangning Hospital of Nanjing Medical University
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Shanghai, China, 200120
- Werving
- Shanghai East Hospital
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Shanghai, China, 200072
- Werving
- Shanghai Tenth People's Hospital
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Shanghai, China, 201304
- Werving
- Shanghai Fifth People's Hospital affiliated to Fudan University
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Shanghai, China, 200336
- Werving
- Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
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Shenyang, China, 110074
- Werving
- Shenyang Fifth People Hospital
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Shenyang, China, 110016
- Werving
- The People's Hospital of Liaoning Province
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Shijiazhuang, China, 050004
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- Hebei Medical University - The Second Hospital
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Zibo, China, 255400
- Werving
- Zibo Municipal Hospital.
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Henan
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Zhengzhou, Henan, China, 450014
- Werving
- The Second Affiliated Hospital of Zhengzhou University
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Shaanxi
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Xianyang, Shaanxi, China, 712000
- Werving
- Yan'an University Xianyang Hospital
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Zhejiang
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Ningbo, Zhejiang, China, 315010
- Werving
- The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
Deelnemers krijgen een bijpassende placebo.
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Participants will receive matching placebo via SC injection as per the schedule in the protocol.
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Percent Change From Baseline in Body Weight at Week 52
Tijdsspanne: Baseline through Week 52
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Baseline through Week 52
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At Week 52
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At Week 52
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Change From Baseline in Body Weight at Week 52
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Triglyceride at Week 52
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline through Week 52
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Baseline through Week 52
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Clinical Trials, Hoffmann-La Roche
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
3 juli 2026
Primaire voltooiing (Geschat)
24 februari 2028
Studie voltooiing (Geschat)
15 maart 2028
Studieregistratiedata
Eerst ingediend
22 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
22 juni 2026
Eerst geplaatst (Werkelijk)
26 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 september 2026
Laatste update ingediend die voldeed aan QC-criteria
8 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- YC46401
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .