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.

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 Sep 2026to 31 Jan 2028
Phase: Phase 2

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

Conditions: Obesity or Overweight
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.

PetrelintideDrug
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 PlaceboDrug
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 group	Role	What they receive
Arm 1: Petrelintide + Enicepatide Dosing Regimen 1	Experimental	Not described Receives: Drug: Petrelintide; Combination Product: Enicepatide
Arm 2: Petrelintide + Enicepatide Dosing Regimen 2	Experimental	Not described Receives: Drug: Petrelintide; Combination Product: Enicepatide
Arm 3: Petrelintide + Enicepatide Dosing Regimen 3	Experimental	Not described Receives: Drug: Petrelintide; Combination Product: Enicepatide
Arm 4: Petrelintide-matching Placebo + Enicepatide	Experimental	Not described Receives: Combination Product: Enicepatide; Drug: Petrelintide-matching Placebo
Arm 5: Petrelintide + Enicepatide-matching Placebo	Experimental	Not described Receives: Drug: Petrelintide; Combination Product: Enicepatide-matching Placebo
Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo	Placebo comparator	Not described Receives: Drug: 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.

Percentage Change in Body Weight between Arms 1 and 6
Measured: From Baseline to Week 40

Secondary outcomes (20)

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

30 Sep 202631 Jan 2028

First posted15 May 2026
Study start30 Sep 2026 (estimated)
Primary completion12 Nov 2027 (estimated)
Study completion31 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity or OverweightStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Sep 2026
First submitted: 11 May 2026
Last updated: 9 Sep 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

Interested in taking part?

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

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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