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NCT Number: NCT07450547

Phase 2 Study to Assess the Safety and Efficacy of ANG003

In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to participate in this study. The primary objective of this study is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved PERT.

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Key information

Conditions

Exocrine Pancreatic Insufficiency (EPI) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Cystic Fibrosis (CF) Digestive System Diseases Exocrine Pancreatic Insufficiency Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Long Beach Memorial Medical Center, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU
  • Confirmed and documented diagnosis of CF
  • Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laboratory.
  • Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening.
  • Adequate nutritional status measured by body mass index (BMI) defined by:
  • BMI ≥25th percentile for children aged 12-17 years
  • BMI ≥18.5 kg/m2 for ≥18 years of age

Exclusion criteria

  • History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening.
  • History of lung or liver transplant, listing for organ transplant or significant bowel resection within the last 6 months. Subjects with a history of resection that does not result in short bowel syndrome are eligible.
  • Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD&C Blue #2).
  • Any chronic diarrheal illness unrelated to pancreatic insufficiency, actively being treated for small intestinal bacterial overgrowth, requiring use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration, Clostridioides difficile infection within 6 months prior to Screening, or severe constipation defined as <1 bowel movement/week.

Treatment and study plan

ANG003 Dose A

Drug

160,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP])

ANG003 Dose B

Drug

240,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP])

CREON

Drug

The 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.

Primary outcomes

  1. Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values

    Time frame: From Visit 1 to Visit 5, anticipated average 80 days

    Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values

  2. Coefficient of Fat Absorption (CFA)

    Time frame: 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 outcomes

  1. Plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) (ug/mL)

    Time frame: Period A (baseline) and Period B time 0, 1, 2, 4, 6, 8, 10 and 24 hour collections

    Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.

  2. Coefficient of Nitrogen Absorption (CNA)

    Time frame: Period A (baseline) and Period B 72 hour CNA collection

    Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.

  3. % of subjects with GI symptoms

    Time frame: From Visit 2 to Visit 5, anticipated average 59 days

    Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.

  4. Cumulative stool weight

    Time frame: Period A (baseline) and Period B 72 hour collection

    Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.

  5. Number of Stools per Day

    Time frame: Period A (baseline) and Period B 72 hour collection

    Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.

Other outcomes

  1. Correlation between DHA/EPA and CFA

    Time frame: Period A (baseline) Period B 72 hour CFA and 24 hour DHA/EPA collection

    Mean change from baseline for each treatment group with a baseline CFA ≥80%

  2. Coefficient of Fat Absorption (CFA) for subjects with a baseline CFA of 60% to <80% (analyzed separately)

    Time frame: Period A (baseline) and Period B 72 hour CFA collection

    Mean change from baseline for each treatment group with a baseline CFA 60% to <80%

  3. Mean Period B CFA for all subjects randomized to the Off Enzyme arm with a baseline CFA ≥80%

    Time frame: Period B 72 hour CFA collection

    Period B CFA Off Enzyme in subjects with a baseline CFA ≥80%

Study contacts

Contact information is provided by the study sponsor or research team.

Evan Bailey, MD

CONTACT

[email protected]

617-466-3111

Sponsors and collaborators

Lead sponsor

Anagram Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Active-controlled Study to Assess the Safety and Efficacy of ANG003 at Two Different Dose Levels in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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