The CeDLara Study is for adults at least 18 years of age who have been diagnosed with celiac disease and are still experiencing symptoms despite following a gluten-free diet.
Why is the research study being conducted?
This study is being done to determine if the study drug reduces symptoms of celiac disease in patients who are on a gluten-free diet and to determine if the study drug changes inflammation in the intestine.
What will occur in this study?
Approximately 525 adults will participate in this research study at approximately 200 clinical centers in North America. Participation in the study will last about 30 weeks. There will be about 8 visits to the study center.
The study will compare two doses of an investigational drug to placebo. A placebo is a capsule that looks like the investigational drug but contains no active ingredients.
You will not be asked to ingest gluten in this study.
You may qualify if you:
- Are 18 years old or older
- Were diagnosed with celiac disease 6 or more months ago
- Are actively experiencing symptoms related to celiac disease
- Have been on a gluten-free diet for at least 6 months
- Are able to maintain a gluten-free diet during your entire study participation
- Are willing to follow a treatment plan of routinely scheduled study visits, lab tests, and other study procedures for the duration of the study
About the Study Sponsor
9 Meters Biopharma, Inc. (“the Company”) is a rare and unmet needs-focused gastroenterology company. The Company is advancing NM-002, a proprietary long-acting GLP-1 agonist into a Phase 2 trial for short bowel syndrome (SBS), a rare, orphan disease, as well as larazotide, a Phase 3 tight junction regulator being evaluated for patient-reported symptom improvement in non-responsive celiac disease.
CeDLara: Phase 3 Study for Celiac Disease