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Trial · Interventional

Not yet recruitingPhase 2Registry data

A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight

Short name ZYNERGY

NCTNCT07589686 (opens ClinicalTrials.gov in a new tab)Other idCC46372
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 2
Enrollment
486 participants (estimated)
Sponsor
Hoffmann-La Roche · Industry
Design
Randomized · Double masking
Countries
Not stated
Start
30 Sept 2026 (estimated)
Primary completion
12 Nov 2027 (estimated)
Completion
31 Jan 2028 (estimated)
First posted
15 May 2026
Last update posted
9 Sept 2026
Conditions
Obesity or Overweight

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 2

    ZYNERGY

    NCT07589686

    est. 30 Sept 2026 to est. 31 Jan 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PetrelintideDrug
  • EnicepatideCombination product
  • Petrelintide-matching PlaceboDrug
  • Enicepatide-matching PlaceboCombination product

Arms6

  • Experimental

    Arm 1: Petrelintide + Enicepatide Dosing Regimen 1

  • Experimental

    Arm 2: Petrelintide + Enicepatide Dosing Regimen 2

  • Experimental

    Arm 3: Petrelintide + Enicepatide Dosing Regimen 3

  • Experimental

    Arm 4: Petrelintide-matching Placebo + Enicepatide

  • Experimental

    Arm 5: Petrelintide + Enicepatide-matching Placebo

  • Placebo comparator

    Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage Change in Body Weight between Arms 1 and 6

    Time frame · From Baseline to Week 40

Secondary outcomes(20)

  1. Percentage Change in Body Weight between Arms 2, 3 and Arm 6

    Time frame · From Baseline to Week 40

  2. Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5

    Time frame · From Baseline to Week 40

  3. Percentage of Participants Achieving Body Weight Loss

    Time frame · From Baseline to Week 40

  4. Change in Body Weight (kilograms [kg])

    Time frame · From Baseline to Week 40

  5. Change in Body Mass Index (kilograms per square meter [kg/m²])

    Time frame · From Baseline to Week 40

  6. Change in Waist Circumference (centimeter [cm])

    Time frame · From Baseline to Week 40

  7. Change in Hemoglobin A1c (HbA1c) (percentage-points)

    Time frame · From Baseline to Week 40

  8. Change in Fasting Insulin

    Time frame · From Baseline to Week 40

  9. Change in Fasting Glucose

    Time frame · From Baseline to Week 40

  10. Change in Systolic Blood Pressure

    Time frame · From Baseline to Week 40

  11. Change in Diastolic Blood Pressure

    Time frame · From Baseline to Week 40

  12. Change in High-Density Lipoprotein (HDL) Cholesterol

    Time frame · From Baseline to Week 40

  13. Change in Low-Density Lipoprotein (LDL) Cholesterol

    Time frame · From Baseline to Week 40

  14. Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol

    Time frame · From Baseline to Week 40

  15. Change in Non-HDL Cholesterol

    Time frame · From Baseline to Week 40

  16. Change in Total Cholesterol

    Time frame · From Baseline to Week 40

  17. Change in Free Fatty Acids

    Time frame · From Baseline to Week 40

  18. Change in Triglycerides

    Time frame · From Baseline to Week 40

  19. Change in High-Sensitivity C-reactive Protein (hsCRP)

    Time frame · From Baseline to Week 40

  20. Number of Participants with Adverse Events (AEs)

    Time frame · From Baseline to Week 40

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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