A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants

NCT07835243 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: GP46978
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of pegozafermin administered in the abdomen, thigh, or upper arm in healthy participants.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Serum Concentration (Cmax) of Pegozafermin

  From predose on Day 1 up to Day 22

• Area Under the Serum Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUClast) of Pegozafermin

  From predose on Day 1 up to Day 22

• Area Under the Serum Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Pegozafermin

  From predose on Day 1 up to Day 22

Secondary Outcomes (8)

• Relative Bioavailability (Frel) of Pegozafermin for Thigh Versus Abdomen

  Up to Day 22

• Frel of Pegozafermin for Upper Arm Versus Abdomen

  Up to Day 22

• Time of Maximum Observed Serum Concentration (Tmax) of Pegozafermin

  From predose on Day 1 up to Day 22

• Terminal Elimination Half-Life (t1/2) of Pegozafermin

  From predose on Day 1 up to Day 22

• Apparent Systemic Clearance (CL/F) of Pegozafermin

  From predose on Day 1 up to Day 22

Study Arms (3)

Group A

EXPERIMENTAL

Participants will receive pegozafermin as per the schedule specified in the protocol in the abdomen.

Drug: Pegozafermin

Group B

EXPERIMENTAL

Participants will receive pegozafermin as per the schedule specified in the protocol in the thigh.

Drug: Pegozafermin

Group C

EXPERIMENTAL

Participants will receive pegozafermin as per the schedule specified in the protocol in the upper arm.

Drug: Pegozafermin

Interventions

Pegozafermin DRUG

Pergozafermin will be administered as specified in the protocol.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a body mass index (BMI) within the range of 18.5-35.0 kilogram per square meter (kg/m²)
• Participants in good health, as determined by medical history, physical examination findings, vital signs, electrocardiogram (ECG), and clinical laboratory tests at screening and prior to dosing
• Participants with willingness and ability to comply with all study requirements

You may not qualify if:

• Participants with a history of pancreatitis or gallbladder/biliary disorders (including cholelithiasis or cholecystitis), clinically significant menstrual abnormalities per investigator judgment, or hypertension
• Participants with known hypersensitivity to pegozafermin or its excipients or history of severe allergic or hypersensitivity reactions that may place the participant at risk
• Participants with any abnormality of the skin such as tattoo(s) or scarring or SC tissue at or near potential injection sites that may interfere with administration or assessment of the injection
• Participants with any history of malignancy
• Participants who are pregnant, breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required
• Participants with a positive result for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies or p24 antigen at screening
• Participants with significant alcohol consumption, defined as \> 14 units/week for females or \> 21 units/week for males
• Participants with a history of recent (i.e., 6 months) bone trauma, fracture, or surgery or other clinically significant bone-related conditions
• Participants with poor peripheral venous access

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GP46978 https://forpatients.roche.com/ No attachments to email below

CONTACT

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

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start (Estimated): October 7, 2026
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): March 2, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share