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

May 11, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

486

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Petrelintide + Enicepatide Dosing Regimen 1
Drug: Petrelintide
Petrelintide will be administered subcutaneously to participants once weekly
Other Names:
  • ZP8396
  • RO7895515
Combination product: Enicepatide
Enicepatide will be administered subcutaneously to participants once weekly
Other Names:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Arm 2: Petrelintide + Enicepatide Dosing Regimen 2
Drug: Petrelintide
Petrelintide will be administered subcutaneously to participants once weekly
Other Names:
  • ZP8396
  • RO7895515
Combination product: Enicepatide
Enicepatide will be administered subcutaneously to participants once weekly
Other Names:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Arm 3: Petrelintide + Enicepatide Dosing Regimen 3
Drug: Petrelintide
Petrelintide will be administered subcutaneously to participants once weekly
Other Names:
  • ZP8396
  • RO7895515
Combination product: Enicepatide
Enicepatide will be administered subcutaneously to participants once weekly
Other Names:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Arm 4: Petrelintide-matching Placebo + Enicepatide
Combination product: Enicepatide
Enicepatide will be administered subcutaneously to participants once weekly
Other Names:
  • RO7795068
  • RG6640
  • CT-388
Drug: Petrelintide-matching Placebo
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
Experimental: Arm 5: Petrelintide + Enicepatide-matching Placebo
Drug: Petrelintide
Petrelintide will be administered subcutaneously to participants once weekly
Other Names:
  • ZP8396
  • RO7895515
Combination product: Enicepatide-matching Placebo
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
Placebo Comparator: Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo
Drug: Petrelintide-matching Placebo
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
Combination product: Enicepatide-matching Placebo
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage Change in Body Weight between Arms 1 and 6
Time Frame: From Baseline to Week 40
From Baseline to Week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage Change in Body Weight between Arms 2, 3 and Arm 6
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Percentage of Participants Achieving Body Weight Loss
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Body Weight (kilograms [kg])
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Body Mass Index (kilograms per square meter [kg/m²])
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Waist Circumference (centimeter [cm])
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Hemoglobin A1c (HbA1c) (percentage-points)
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Fasting Insulin
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Fasting Glucose
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Systolic Blood Pressure
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Diastolic Blood Pressure
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in High-Density Lipoprotein (HDL) Cholesterol
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Low-Density Lipoprotein (LDL) Cholesterol
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Non-HDL Cholesterol
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Total Cholesterol
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Free Fatty Acids
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in Triglycerides
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Change in High-Sensitivity C-reactive Protein (hsCRP)
Time Frame: From Baseline to Week 40
From Baseline to Week 40
Number of Participants with Adverse Events (AEs)
Time Frame: From Baseline to Week 40
From Baseline to Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Zealand Pharma

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

November 12, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC46372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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