A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight (ZYNERGY)
7 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
486
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studera Kontakt Backup
- Namn: Reference Study ID Number: CC46372 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. Only)
- E-post: global-roche-genentech-trials@gene.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm 1: Petrelintide + Enicepatide Dosing Regimen 1
|
Petrelintide will be administered subcutaneously to participants once weekly
Andra namn:
Enicepatide will be administered subcutaneously to participants once weekly
Andra namn:
|
|
Experimentell: Arm 2: Petrelintide + Enicepatide Dosing Regimen 2
|
Petrelintide will be administered subcutaneously to participants once weekly
Andra namn:
Enicepatide will be administered subcutaneously to participants once weekly
Andra namn:
|
|
Experimentell: Arm 3: Petrelintide + Enicepatide Dosing Regimen 3
|
Petrelintide will be administered subcutaneously to participants once weekly
Andra namn:
Enicepatide will be administered subcutaneously to participants once weekly
Andra namn:
|
|
Experimentell: Arm 4: Petrelintide-matching Placebo + Enicepatide
|
Enicepatide will be administered subcutaneously to participants once weekly
Andra namn:
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
|
|
Experimentell: Arm 5: Petrelintide + Enicepatide-matching Placebo
|
Petrelintide will be administered subcutaneously to participants once weekly
Andra namn:
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
|
|
Placebo-jämförare: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentage Change in Body Weight between Arms 1 and 6
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentage Change in Body Weight between Arms 2, 3 and Arm 6
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Percentage of Participants Achieving Body Weight Loss
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Body Weight (kilograms [kg])
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Body Mass Index (kilograms per square meter [kg/m²])
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Waist Circumference (centimeter [cm])
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Hemoglobin A1c (HbA1c) (percentage-points)
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Fasting Insulin
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Fasting Glucose
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Systolic Blood Pressure
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Diastolic Blood Pressure
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in High-Density Lipoprotein (HDL) Cholesterol
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Non-HDL Cholesterol
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Total Cholesterol
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Free Fatty Acids
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Triglycerides
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in High-Sensitivity C-reactive Protein (hsCRP)
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
|
Number of Participants with Adverse Events (AEs)
Tidsram: From Baseline to Week 40
|
From Baseline to Week 40
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Clinical Trials, Hoffmann-La Roche
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 september 2026
Primärt slutförande (Beräknad)
12 november 2027
Avslutad studie (Beräknad)
31 januari 2028
Studieregistreringsdatum
Först inskickad
11 maj 2026
Först inskickad som uppfyllde QC-kriterierna
11 maj 2026
Första postat (Faktisk)
15 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CC46372
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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