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NCT Number: NCT07589686

A Dose-Finding Study of Petrelintide With Enicepatide (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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Petrelintide

Drug

Petrelintide will be administered subcutaneously to participants once weekly

Other names: RO7895515, ZP8396

Enicepatide

Combination Product

Enicepatide will be administered subcutaneously to participants once weekly

Other names: RO7795068, CT-388, RG6640

Petrelintide-matching Placebo

Drug

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

Enicepatide-matching Placebo

Combination Product

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

Primary outcomes

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

    Time frame: From Baseline to Week 40

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Zealand Pharma

Registry information

Official study 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

Acronym: ZYNERGY

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 15, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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