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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
486

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zealand Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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