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PG-102

Phase 2

Type 2 Diabetes Mellitus (T2DM) | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Sep 23, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07187856Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes MellitusPHASE2 NOT YET_RECRUITING 80Jan 1, 2026Dec 1, 2026Sep 23, 20251 Australia
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Study Endpoints
Primary Endpoints
Absolute change in HbA1c From Baseline at Week 24
24 weeks

Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo.

Secondary Endpoints
Absolute change in HbA1c from baseline to 12 weeks
12 weeks
Absolute Change in Body Weight From Baseline at Week 12 and 24
12 and 24 weeks
Percent Change in Body Weight From Baseline at Week 12 and 24
12 and 24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PG-102EXPERIMENTALParticipants receive PG-102 administered subcutaneously once weekly with dose titration.
PlaceboPLACEBO_COMPARATORParticipants receive matching placebo administered subcutaneously once weekly.
SemaglutideACTIVE_COMPARATORParticipants receive open-label semaglutide administered subcutaneously once weekly, titrated to 1.0 mg.
Interventions
NameTypeDescription
PG-102DRUGPG-102 is administered subcutaneously once weekly with a titration regimen.
PlaceboDRUGPlacebo is administered subcutaneously once weekly.
SemaglutideDRUGOpen-label semaglutide is administered subcutaneously once weekly with titration regimen.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. * Adult males and females, 18 to 75 years of age (inclusive) on the...

Countries:Australia
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