A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight (ZYNERGY)
11. maj 2026 opdateret af: Hoffmann-La Roche
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Petrelintide Co-Administered With RO7795068 in Adults With Obesity or Overweight
The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
486
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Reference Study ID Number: CC46372 https://forpatients.roche.com/
- Telefonnummer: 888-662-6728 (U.S. Only)
- E-mail: global-roche-genentech-trials@gene.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Key Inclusion Criteria:
- Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to < 30 kg/m² with at least one weight-related comorbidity
- History of at least one self-reported unsuccessful dietary effort to lose body weight
Key Exclusion Criteria:
- HbA1c ≥ 48 mmol/mol (6.5%) at screening
- History of Type 1 or Type 2 Diabetes
- Self-reported change in body weight > 5 kg within 90 days prior to screening
- Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed > 1 year prior to or during screening)
- Previous or planned endoscopic and/or device-based obesity treatment or removal or device within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal endoluminal liner)
- Treatment with any GLP-1 receptor agonist, GLP-1/GIP receptor agonist (or any other GLP-1 based treatment) within 180 days prior to or during screening
- Current or previous treatment with petrelintide or any other amylin analog
- Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity
- History of severe psychiatric disorders
- History of any hematologic conditions that may interfere with HbA1c measurement
- Known history or presence of pancreatitis
- Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility
- New York Heart Association Functional Classification IV heart failure
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1: Petrelintide + Enicepatide Dosing Regimen 1
|
Petrelintide will be administered subcutaneously to participants once weekly
Andre navne:
Enicepatide will be administered subcutaneously to participants once weekly
Andre navne:
|
|
Eksperimentel: Arm 2: Petrelintide + Enicepatide Dosing Regimen 2
|
Petrelintide will be administered subcutaneously to participants once weekly
Andre navne:
Enicepatide will be administered subcutaneously to participants once weekly
Andre navne:
|
|
Eksperimentel: Arm 3: Petrelintide + Enicepatide Dosing Regimen 3
|
Petrelintide will be administered subcutaneously to participants once weekly
Andre navne:
Enicepatide will be administered subcutaneously to participants once weekly
Andre navne:
|
|
Eksperimentel: Arm 4: Petrelintide-matching Placebo + Enicepatide
|
Enicepatide will be administered subcutaneously to participants once weekly
Andre navne:
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
|
|
Eksperimentel: Arm 5: Petrelintide + Enicepatide-matching Placebo
|
Petrelintide will be administered subcutaneously to participants once weekly
Andre navne:
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
|
|
Placebo komparator: Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo
|
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage Change in Body Weight between Arms 1 and 6
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage Change in Body Weight between Arms 2, 3 and Arm 6
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Percentage of Participants Achieving Body Weight Loss
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Body Weight (kilograms [kg])
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Body Mass Index (kilograms per square meter [kg/m²])
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Waist Circumference (centimeter [cm])
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Hemoglobin A1c (HbA1c) (percentage-points)
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Fasting Insulin
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Fasting Glucose
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Systolic Blood Pressure
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Diastolic Blood Pressure
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in High-Density Lipoprotein (HDL) Cholesterol
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Non-HDL Cholesterol
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Total Cholesterol
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Free Fatty Acids
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Triglycerides
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in High-Sensitivity C-reactive Protein (hsCRP)
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Number of Participants with Adverse Events (AEs)
Tidsramme: From Baseline to Week 40
|
From Baseline to Week 40
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. juni 2026
Primær færdiggørelse (Anslået)
12. november 2027
Studieafslutning (Anslået)
31. januar 2028
Datoer for studieregistrering
Først indsendt
11. maj 2026
Først indsendt, der opfyldte QC-kriterier
11. maj 2026
Først opslået (Faktiske)
15. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CC46372
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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