ZYNERGY

Not yet recruitingPhase 2

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

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

Lead sponsor

Hoffmann-La Roche

Assets

CT-388 / Petrelintide

Listed sites

Recruiting sites

—

Enrollment

486

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

Identifiers

Registered as

NCT IDNCT07589686

Org study IDCC46372

Timeline

Milestones

Study first posted2026-05-15actual

Last update posted2026-05-15actual

Study start2026-06-30estimated

Primary completion2027-11-12estimated

Study completion2028-01-31estimated

Assets

Investigational agents

CT-388 Petrelintide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

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

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

7 endpoints

Primary/protocol endpoint

Percentage Change in Body Weight between Arms 1 and 6

Time frame:From Baseline to Week 40

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From Baseline to Week 40

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From Baseline to Week 40

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Achieving Body Weight Loss

Time frame:From Baseline to Week 40

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Weight (kilograms [kg])

Time frame:From Baseline to Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From Baseline to Week 40

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference (centimeter [cm])

Time frame:From Baseline to Week 40

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

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

Time frame:From Baseline to Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change in Fasting Insulin

Time frame:From Baseline to Week 40

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Glucose

Time frame:From Baseline to Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:From Baseline to Week 40

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:From Baseline to Week 40

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in High-Density Lipoprotein (HDL) Cholesterol

Time frame:From Baseline to Week 40

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low-Density Lipoprotein (LDL) Cholesterol

Time frame:From Baseline to Week 40

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

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

Time frame:From Baseline to Week 40

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Non-HDL Cholesterol

Time frame:From Baseline to Week 40

Non-HDL cholesterol, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:From Baseline to Week 40

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Free Fatty Acids

Time frame:From Baseline to Week 40

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Triglycerides

Time frame:From Baseline to Week 40

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

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

Time frame:From Baseline to Week 40

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of Participants with Adverse Events (AEs)

Time frame:From Baseline to Week 40

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.