Recent Updates
Recently added Catalysts

Pegozafermin

Phase 3

Undisclosed | Small Molecules | Other |Roche Holding AG|Trials Updated: Oct 19, 2026

Pegozafermin development status

Highest phase Phase 3 run by Hoffmann-La Roche (NCT06318169)
Phase scored for RHHBYPhase 1
Registered trials 6 across 2 sponsors since Aug 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Pegozafermin clinical trials

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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...

Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWOct 19, 2026NCT07835243startDate: changed
LOWOct 19, 2026NCT07835243startDate: changed
LOWOct 19, 2026NCT07835243startDate: changed
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 (ticker RHHBY). It is currently in Phase 1 clinical development. The specific disease indications for pegozafermin have not been disclosed, and the program is categorized under a therapeutic area outside the main disease categories tracked.

Who is developing Pegozafermin?

Pegozafermin is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating pegozafermin. The drug is an investigational small molecule and remains in Phase 1 development.

What phase is Pegozafermin in?

Pegozafermin is in Phase 1 clinical development. It is an investigational small molecule and has not been approved for any indication. One Phase 1 trial is registered, and it is currently listed as not yet recruiting.

What clinical trials is Pegozafermin in?

Pegozafermin is being studied in one registered Phase 1 trial, NCT07835243, titled a study to assess the effect of subcutaneous injection site on the pharmacokinetics of pegozafermin in healthy participants. The trial is controlled, randomized, and plans to enroll 105 healthy volunteers aged 18 years and older. It is not yet recruiting.

Is Pegozafermin FDA approved?

Pegozafermin is not approved. It is an investigational small molecule in Phase 1 clinical development, and its only registered trial is a pharmacokinetic study in healthy volunteers. No approval status has been granted for any indication.