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

October 16, 2026 updated by: Hoffmann-La Roche

A Phase 1, Open-Label, Randomized, Single-Dose Study to Evaluate the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: Reference Study ID Number: GP46978 https://forpatients.roche.com/ No attachments to email below
  • Phone Number: 888-662-6728 (U.S. and Canada)
  • Email: global-roche-genentech-trials@gene.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A

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

Pergozafermin will be administered as specified in the protocol.
Experimental: Group B

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

Pergozafermin will be administered as specified in the protocol.
Experimental: Group C

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

Pergozafermin will be administered as specified in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Serum Concentration (Cmax) of Pegozafermin
Time Frame: From predose on Day 1 up to Day 22
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
Time Frame: From predose on Day 1 up to Day 22
From predose on Day 1 up to Day 22
Area Under the Serum Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Pegozafermin
Time Frame: From predose on Day 1 up to Day 22
From predose on Day 1 up to Day 22

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative Bioavailability (Frel) of Pegozafermin for Thigh Versus Abdomen
Time Frame: Up to Day 22
Up to Day 22
Frel of Pegozafermin for Upper Arm Versus Abdomen
Time Frame: Up to Day 22
Up to Day 22
Time of Maximum Observed Serum Concentration (Tmax) of Pegozafermin
Time Frame: From predose on Day 1 up to Day 22
From predose on Day 1 up to Day 22
Terminal Elimination Half-Life (t1/2) of Pegozafermin
Time Frame: From predose on Day 1 up to Day 22
From predose on Day 1 up to Day 22
Apparent Systemic Clearance (CL/F) of Pegozafermin
Time Frame: From predose on Day 1 up to Day 22
From predose on Day 1 up to Day 22
Apparent Volume of Distribution (Vz/F) of Pegozafermin
Time Frame: From predose on Day 1 up to Day 22
From predose on Day 1 up to Day 22
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Time Frame: Up to approximately 50 days
Up to approximately 50 days
Number of Participants With Injection Site Reactions (ISRs)
Time Frame: Up to 24 hours post-dose on Day 1
Up to 24 hours post-dose on Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 5, 2026

Primary Completion (Estimated)

March 2, 2027

Study Completion (Estimated)

March 2, 2027

Study Registration Dates

First Submitted

September 17, 2026

First Submitted That Met QC Criteria

September 17, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

October 19, 2026

Last Update Submitted That Met QC Criteria

October 16, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GP46978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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