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ANG003 Dose A

Phase 2

Exocrine Pancreatic Insufficiency (EPI) | Small molecule | Respiratory |cbdMD, Inc.|Last Updated: Aug 27, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment113

FDA Designations

No designations recorded

Clinical trial landscape

ANG003 Dose A · 1 trial · 2 indications

Phase 2 1
NCT07450547Phase 2 Study to Assess the Safety and Efficacy of ANG003Exocrine Pancreatic Insufficiency (EPI)
RECRUITING113 Analytics
PHASE2RECRUITING
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI)
NCT07450547113
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Study Endpoints

Primary Endpoints

Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values
From Visit 1 to Visit 5, anticipated average 80 days
Coefficient of Fat Absorption (CFA)
Period A (baseline) and Period B 72 hour CFA collection

Mean change from baseline CFA (i.e., Period B CFA minus Period A CFA) assessed for ANG003 Dose A, ANG003 Dose B, and Creon amongst subjects with baseline CFA ≥80%.

Secondary Endpoints

Plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) (ug/mL)
Period A (baseline) and Period B time 0, 1, 2, 4, 6, 8, 10 and 24 hour collections
Coefficient of Nitrogen Absorption (CNA)
Period A (baseline) and Period B 72 hour CNA collection
% of subjects with GI symptoms
From Visit 2 to Visit 5, anticipated average 59 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ANG003 Dose AEXPERIMENTALAll subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is \>/= 80%, the subject may be randomized to ANG003 Dose A for a 21-day acclimation and subsequent CFA analysis.
ANG003 Dose BEXPERIMENTALAll subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is \>/= 80%, the subject may be randomized to ANG003 Dose B for a 21-day acclimation and subsequent CFA analysis.
CreonACTIVE_COMPARATORAll subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is \>/= 80%, the subject may be randomized to Creon for an additional 21-days and subsequent CFA analysis.
Off EnzymeNO_INTERVENTIONAll subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is \>/= 80%, the subject may be randomized to the off enzyme arm. Subjects will receive Creon for an additional 21-day and the subsequent CFA analysis will be off enzyme. Total time off enzyme will be 4-7 days.
60% to <80% CFA ANG003 Dose BOTHERAll subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. Participants with a Period A CFA result of 60% to \<80% will be assigned to ANG003 Dose B.

Interventions

NameTypeDescription
ANG003 Dose ADRUG160,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
ANG003 Dose BDRUG240,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
CreonDRUGThe commercially available pPERT Creon will be the active comparator in the study. Subjects will be instructed to take Creon according to the package insert and PI direction.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: 1. Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU 2. Confirmed and documented diagnosis of CF 3. Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laborator...

Countries:United States
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