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New enzyme pill could help cystic fibrosis patients digest food better

NCT ID NCT07450547

Disease control Sponsor: Anagram Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 16 times

Summary

This study tests a new medicine called ANG003 for people with cystic fibrosis who have trouble digesting food (exocrine pancreatic insufficiency). The medicine is a type of enzyme replacement therapy, similar to the current standard treatment Creon. About 113 participants will receive either ANG003 or Creon to see if the new treatment is safe and works as well. The main goal is to measure how well the body absorbs fat and to check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ANG003 (a pancreatic enzyme replacement therapy)
What this could lead to
If it works, this could offer a new treatment option for people with cystic fibrosis who have trouble digesting food due to pancreatic insufficiency.
What could go wrong
This is an early Phase 2 trial with only 113 participants, so results may not apply to everyone. The new therapy might not work better than the current standard treatment, Creon.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 113 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 laboratory. 4. Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening. 5. Adequate nutritional status measured by body mass index (BMI) defined by: 1. BMI ≥25th percentile for children aged 12-17 years 2. BMI ≥18.5 kg/m2 for ≥18 years of age Exclusion Criteria: 1. History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening. 2. 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. 3. Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2). 4. 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.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis exocrine pancreatic insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis (CF) Exocrine pancreatic insufficiency (EPI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Adult Cystic Fibrosis Center at the University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Boston Children's Hospita

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Center for Cystic Fibrosis at Keck Medical Center of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • Central Florida Pulmonary Group

    NOT_YET_RECRUITING

    Orlando, Florida, 32803, United States

  • Children's Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308, United States

  • Froedtert & Medical College of Wisconsin

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Hershey Medical Center Pennsylvania State University

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Long Beach Memorial Medical Center

    RECRUITING

    Long Beach, California, 90806, United States

  • MaineHealth Pediatric Specialty Care

    NOT_YET_RECRUITING

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Nationwide Children's Hospital, Columbus

    NOT_YET_RECRUITING

    Columbus, Ohio, 43205, United States

  • New York Medical College at Westchester Medical Center

    NOT_YET_RECRUITING

    Valhalla, New York, 10595, United States

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

    Contact Email: •••••@•••••

  • Rutgers - Robert Wood Johnson Medical School

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • The Cystic Fibrosis Institute

    RECRUITING

    Glenview, Illinois, 60025, United States

  • Toledo Children's Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • University of Florida

    NOT_YET_RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Iowa

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

  • University of Michigan, Michigan Medicine

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Texas Southwestern / Children's Health

    RECRUITING

    Dallas, Texas, 75207, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Wayne State University Harper University Hospital

    RECRUITING

    Detroit, Michigan, 48201, United States

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