Trial studying safety and effects for Exocrine Pancreatic Insufficiency (EPI)
Official title Phase 2 Study to Assess the Safety and Efficacy of ANG003
ClinicalTrials.gov ID: NCT07450547
What this study is testing
What is ANG003 Dose A?
investigational pancreatic enzyme replacement therapy being studied for exocrine pancreatic insufficiency is designed to provide lipase, protease, and amylase enzymes to aid digestion
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if ANG003 is safe and works as well as the approved enzyme medicine Creon for pancreatic insufficiency in cystic fibrosis.
- Who it's for
- People with cystic fibrosis who have exocrine pancreatic insufficiency.
- What's involved
- Participants will take ANG003 or Creon and have regular check‑ups and lab tests to monitor safety and how well the enzymes work.
- Time commitment
- The trial runs for several months with multiple clinic visits for dosing and assessments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male and female people 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.
- BMI ≥25th percentile for children aged 12-17 years
You likely can't join if
- 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.
- 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...
See the full eligibility criteria
- Male and female people 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.
- BMI ≥25th percentile for children aged 12-17 years
- BMI ≥18.5 kg/m2 for ≥18 years of age
- 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. people 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Long Beach, California, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Atlanta, Georgia, United States
- Glenview, Illinois, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- New Brunswick, New Jersey, United States
- Akron, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Toledo, Ohio, United States
- Hershey, Pennsylvania, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Long Beach, California, United States; Los Angeles, California, United States; Denver, Colorado, United States; Atlanta, Georgia, United States; Glenview, Illinois, United States; Kansas City, Kansas, United States and 14 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.