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Obesity or OverweightPhase 2ZYNERGYNCT07589686

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

A Phase 2 study testing Petrelintide and Enicepatide in people with Obesity or Overweight, run by Hoffmann-La Roche.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity or Overweight
What is being tested?
Petrelintide and Enicepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
486 participants
Where
No sites listed yet
Study dates
30 Nov 2026to 31 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: CC46372 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

About this study

Official title: 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.

Being tested
Petrelintide, Enicepatide, Petrelintide-matching Placebo, Enicepatide-matching Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PetrelintideCombination product

    Also called RO7895515, ZP8396

    Petrelintide will be administered subcutaneously to participants once weekly

  • EnicepatideCombination product

    Also called RO7795068, CT-388, RG6640

    Enicepatide will be administered subcutaneously to participants once weekly

  • Petrelintide-matching PlaceboCombination product

    Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly

  • Enicepatide-matching PlaceboCombination product

    Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly

Study groups in NCT07589686
Study groupRoleWhat they receive
Arm 1: Petrelintide + Enicepatide Dosing Regimen 1ExperimentalNot described
Receives: Combination Product: Petrelintide; Combination Product: Enicepatide
Arm 2: Petrelintide + Enicepatide Dosing Regimen 2ExperimentalNot described
Receives: Combination Product: Petrelintide; Combination Product: Enicepatide
Arm 3: Petrelintide + Enicepatide Dosing Regimen 3ExperimentalNot described
Receives: Combination Product: Petrelintide; Combination Product: Enicepatide
Arm 4: Petrelintide-matching Placebo + EnicepatideExperimentalNot described
Receives: Combination Product: Enicepatide; Combination Product: Petrelintide-matching Placebo
Arm 5: Petrelintide + Enicepatide-matching PlaceboExperimentalNot described
Receives: Combination Product: Petrelintide; Combination Product: Enicepatide-matching Placebo
Arm 6: Petrelintide-matching Placebo + Enicepatide-matching PlaceboPlacebo comparatorNot described
Receives: Combination Product: Petrelintide-matching Placebo; Combination Product: Enicepatide-matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From Baseline to Week 40

Secondary outcomes (20)

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

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

  3. Percentage of Participants Achieving Body Weight Loss

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

  8. Change in Fasting Insulin

    Measured: From Baseline to Week 40

  9. Change in Fasting Glucose

    Measured: From Baseline to Week 40

  10. Change in Systolic Blood Pressure

    Measured: From Baseline to Week 40

  11. Change in Diastolic Blood Pressure

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

  15. Change in Non-HDL Cholesterol

    Measured: From Baseline to Week 40

  16. Change in Total Cholesterol

    Measured: From Baseline to Week 40

  17. Change in Free Fatty Acids

    Measured: From Baseline to Week 40

  18. Change in Triglycerides

    Measured: From Baseline to Week 40

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

    Measured: From Baseline to Week 40

  20. Number of Participants with Adverse Events (AEs)

    Measured: From Baseline to Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion12 Nov 2027 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
486 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07589686
Sponsor's protocol ID
CC46372
Acronym
ZYNERGY
Status last verified
Oct 2026
First submitted
11 May 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Petrelintide and Enicepatide in people with Obesity or Overweight, run by Hoffmann-La Roche.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: CC46372 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Body Weight between Arms 1 and 6 (time frame: From Baseline to Week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07589686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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