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

NCT07589686 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: CC46372
• Study Type: interventional
• Target: 486
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity or Overweight

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Body Weight between Arms 1 and 6

  From Baseline to Week 40

Secondary Outcomes (20)

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

  From Baseline to Week 40

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

  From Baseline to Week 40

• Percentage of Participants Achieving Body Weight Loss

  From Baseline to Week 40

• Change in Body Weight (kilograms [kg])

  From Baseline to Week 40

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

  From Baseline to Week 40

Study Arms (6)

Arm 1: Petrelintide + Enicepatide Dosing Regimen 1

EXPERIMENTAL

Drug: Petrelintide; Combination Product: Enicepatide

Arm 2: Petrelintide + Enicepatide Dosing Regimen 2

EXPERIMENTAL

Drug: Petrelintide; Combination Product: Enicepatide

Arm 3: Petrelintide + Enicepatide Dosing Regimen 3

EXPERIMENTAL

Drug: Petrelintide; Combination Product: Enicepatide

Arm 4: Petrelintide-matching Placebo + Enicepatide

EXPERIMENTAL

Combination Product: Enicepatide; Drug: Petrelintide-matching Placebo

Arm 5: Petrelintide + Enicepatide-matching Placebo

EXPERIMENTAL

Drug: Petrelintide; Combination Product: Enicepatide-matching Placebo

Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo

PLACEBO COMPARATOR

Drug: Petrelintide-matching Placebo; Combination Product: Enicepatide-matching Placebo

Interventions

Petrelintide DRUG

Petrelintide will be administered subcutaneously to participants once weekly

Also known as: RO7895515, ZP8396

Arm 1: Petrelintide + Enicepatide Dosing Regimen 1; Arm 2: Petrelintide + Enicepatide Dosing Regimen 2; Arm 3: Petrelintide + Enicepatide Dosing Regimen 3; Arm 5: Petrelintide + Enicepatide-matching Placebo

Enicepatide COMBINATION_PRODUCT

Enicepatide will be administered subcutaneously to participants once weekly

Also known as: RO7795068, CT-388, RG6640

Arm 1: Petrelintide + Enicepatide Dosing Regimen 1; Arm 2: Petrelintide + Enicepatide Dosing Regimen 2; Arm 3: Petrelintide + Enicepatide Dosing Regimen 3; Arm 4: Petrelintide-matching Placebo + Enicepatide

Petrelintide-matching Placebo DRUG

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

Arm 4: Petrelintide-matching Placebo + Enicepatide; Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo

Enicepatide-matching Placebo COMBINATION_PRODUCT

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

Arm 5: Petrelintide + Enicepatide-matching Placebo; Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Zealand Pharma: collaborator

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CC46372 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): November 12, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share