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Pegozafermin

Phase 3

Healthy Volunteers | Small molecule | Other |Roche Holding AG|Last Updated: Sep 22, 2026

Development status

Highest phase Phase 3 run by 89bio, Inc. (NCT06318169)
Phase scored for RHHBYPhase 1
Registered trials 6 across 2 sponsors since Aug 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

Pegozafermin · 1 trial · 1 indication

Phase 1 1
NCT07835243A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy ParticipantsHealthy Volunteers
NOT YET_RECRUITING105 Analytics
PHASE1NOT YET_RECRUITING
A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALParticipants will receive pegozafermin as per the schedule specified in the protocol in the abdomen.
Group BEXPERIMENTALParticipants will receive pegozafermin as per the schedule specified in the protocol in the thigh.
Group CEXPERIMENTALParticipants will receive pegozafermin as per the schedule specified in the protocol in the upper arm.

Interventions

NameTypeDescription
PegozaferminDRUGPergozafermin will be administered as specified in the protocol.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes

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 scre...

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Recent Changes (Last 90 Days)

LOWSep 22, 2026NCT07835243NEW_TRIAL: changed
LOWSep 22, 2026NCT07835243NEW_TRIAL: changed

Frequently asked questions about Pegozafermin

What is Pegozafermin?

Pegozafermin is an investigational small molecule being developed by Roche Holding AG. It is currently in Phase 1 clinical development and is being studied in healthy volunteers. The single registered trial is designed to assess how the injection site affects the pharmacokinetics of pegozafermin when given as a subcutaneous injection.

Who is developing Pegozafermin?

Pegozafermin is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the Phase 1 program evaluating the drug in healthy volunteers.

What phase is Pegozafermin in?

Pegozafermin is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program currently consists of one registered trial in healthy volunteers, and that trial has not yet begun recruiting participants.

What clinical trials is Pegozafermin in?

Pegozafermin is being studied in one registered clinical trial, NCT07835243, titled A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants. The Phase 1 trial is not yet recruiting and is expected to enroll 105 healthy volunteers aged 18 years and older.

How is the Pegozafermin trial designed?

The Phase 1 trial NCT07835243 is a controlled, randomized study of pegozafermin given by subcutaneous injection to healthy volunteers. It is not double blinded. The study is designed to assess the effect of the subcutaneous injection site on the pharmacokinetics of pegozafermin, and it plans to enroll 105 participants.