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New pill aims to help cystic fibrosis patients digest food

NCT ID NCT06052293

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new medicine called ANG003 in 57 adults with cystic fibrosis who have trouble digesting food due to a lack of digestive enzymes. Participants took a single dose of the drug with a meal to see if it was safe and helped with digestion. The goal was to find the right dose and check for side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

57 people

The number who actually took part.

Started

Aug 2023

Finished

Jul 2024

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

18 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 18 years of age or older. 2. Confirmed diagnosis of CF defined as: a) CF signs and symptoms AND b) Two CF-causing mutations on genetic testing or sweat chloride \>60 mEq/L. 3. Documented history of fecal elastase \<100 µg/g stool. 4. EPI clinically controlled with minimal clinical symptoms and on a stable dose of PERT for 90 days before screening as determined by the Investigator. 5. Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects. Exclusion Criteria: 1. Subjects with diabetes mellitus who are unable to refrain from short-acting and rapid-acting insulin on Days 1 and 5 for a daily total of 6 hours. 2. Involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of \>5% of body weight within 1 month. 3. Requires use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration. 4. CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2). 5. Subjects who cannot discontinue omega-3 supplements \>500 mg of DHA and EPA daily. 6. Subjects unable to tolerate missing a dose of PERT.

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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.

Exocrine pancreatic insufficiency

Contacts and locations

Locations

  • Akron Childrens Hospital

    Akron, Ohio, 44308, United States

  • Albany Medical College

    Albany, New York, 12208, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Harper University Hospital / Wayne State University

    Detroit, Michigan, 48201, United States

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806, United States

  • Massachusetts General Hospital,

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • New York Medical College at Westchester Medical Center

    Valhalla, New York, 10595, United States

  • Norton Children's Research Institute affiliated with University of Louisville School of Medicine

    Louisville, Kentucky, 40202, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

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