Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

8. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

300

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studieren Sie die Kontaktsicherung

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

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Die Teilnehmer erhalten ein passendes Placebo.
Kombinationsprodukt: 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.
Kombinationsprodukt: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Andere Namen:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Enicepatide Dose 2
Participants will receive enicepatide Dose 2.
Kombinationsprodukt: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Andere Namen:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Enicepatide Dose 3
Participants will receive enicepatide Dose 3.
Kombinationsprodukt: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Andere Namen:
  • RO7795068
  • RG6640
  • CT-388

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Percent Change From Baseline in Body Weight at Week 52
Zeitfenster: Baseline through Week 52
Baseline through Week 52

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Ermittler

  • Studienleiter: Clinical Trials, Hoffmann-La Roche

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. Juli 2026

Primärer Abschluss (Geschätzt)

24. Februar 2028

Studienabschluss (Geschätzt)

15. März 2028

Studienanmeldedaten

Zuerst eingereicht

22. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • YC46401

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren