Phase 3 Crohn's Disease and Colitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with Crohn's disease (CD) or Crohn's disease that affects the area around the anus (perianal fistulizing CD)
- People with a BMI of 30 or higher (classified as obese), OR people with a BMI between 27 and under 30 (classified as overweight) who also have at least one weight-related health condition such as high blood pressure, Type 2 diabetes, high cholesterol or triglycerides, obstructive sleep apnea, or heart disease
- People whose Crohn's disease is moderately to severely active, based on a specific disease activity score (called CDAI) of at least 220 at the start of the trial
- People whose bowel inflammation, as seen during an internal camera examination (endoscopy), meets a specific minimum score within 21 days before the first dose of the study treatment (confirm specific score requirements with trial site)
- People who have had Crohn's disease for 8 or more years affecting mainly or only the colon must have had a bowel cancer screening within the past year showing no signs of abnormal or cancerous cells
- People whose Crohn's disease has not responded well to, stopped responding to, or who could not tolerate at least one standard or advanced treatment for CD
Who may not be able to join:
- People who have been diagnosed with Ulcerative Colitis, unclassified inflammatory bowel disease, or a liver condition called primary sclerosing cholangitis
- People who are missing more than two of the five main sections of the bowel examined in this trial (confirm with trial site)
- People who currently have, or are suspected to have, an abscess (a pocket of infection)
- People who have a stoma, an ileoanal pouch, or an ostomy (surgically created openings or pouches in the digestive system)
- People who have had more than three surgeries to remove part of the small bowel, had more than 100 centimetres of small bowel removed in total, have been diagnosed with short bowel syndrome, or have had any abdominal surgery in the three months before the start of the trial
- People who have Type 1 diabetes, or Type 2 diabetes that is treated with insulin
- People who have experienced severe low blood sugar episodes or who do not notice the warning signs of low blood sugar, within the six months before screening
- People whose body weight has changed by more than 5% in the past three months
- People who currently have or have recently had an active infection
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Phone: 1-317-615-4559
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.