Healthy VolunteersPhase 1NCT07835243
A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
A Phase 1 study testing Pegozafermin in people with Healthy Volunteers, run by Hoffmann-La Roche.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Pegozafermin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2026to 2 Mar 2027
- Phase
- Phase 1
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
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: GP46978 https://forpatients.roche.com/ No attachments to email below contact
Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry contact
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- Pegozafermin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegozaferminDrug
Pergozafermin will be administered as specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants will receive pegozafermin as per the schedule specified in the protocol in the abdomen. Receives: Drug: Pegozafermin |
| Group B | Experimental | Participants will receive pegozafermin as per the schedule specified in the protocol in the thigh. Receives: Drug: Pegozafermin |
| Group C | Experimental | Participants will receive pegozafermin as per the schedule specified in the protocol in the upper arm. Receives: Drug: Pegozafermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax) of Pegozafermin
Measured: 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
Measured: From predose on Day 1 up to Day 22
Area Under the Serum Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Pegozafermin
Measured: From predose on Day 1 up to Day 22
Secondary outcomes (8)
Relative Bioavailability (Frel) of Pegozafermin for Thigh Versus Abdomen
Measured: Up to Day 22
Frel of Pegozafermin for Upper Arm Versus Abdomen
Measured: Up to Day 22
Time of Maximum Observed Serum Concentration (Tmax) of Pegozafermin
Measured: From predose on Day 1 up to Day 22
Terminal Elimination Half-Life (t1/2) of Pegozafermin
Measured: From predose on Day 1 up to Day 22
Apparent Systemic Clearance (CL/F) of Pegozafermin
Measured: From predose on Day 1 up to Day 22
Apparent Volume of Distribution (Vz/F) of Pegozafermin
Measured: 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)
Measured: Up to approximately 50 days
Number of Participants With Injection Site Reactions (ISRs)
Measured: Up to 24 hours post-dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start5 Nov 2026 (estimated)
- Primary completion2 Mar 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835243
- Sponsor's protocol ID
- GP46978
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No