Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT06937086 Sponsor: Eli Lilly and Company Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT06937086
Recruiting Phase 3

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who have been diagnosed with ulcerative colitis (UC) for at least 3 months, with the diagnosis confirmed by a camera examination of the bowel and a tissue sample report.
  • People whose UC is moderately to severely active, based on a specific scoring system (called a modified Mayo score) measured by a bowel camera examination within 21 days before the study starts.
  • People who have had UC for 8 or more years and have had a bowel cancer screening colonoscopy within the past year, with results showing no signs of abnormal cell changes or cancer.
  • People with obesity, meaning a body mass index (BMI) of 30 or above.
  • People who are overweight (BMI of 27 up to less than 30) and also have at least one of the following weight-related health conditions: high blood pressure, type 2 diabetes, high cholesterol or abnormal blood fats, obstructive sleep apnea, or cardiovascular (heart) disease.
  • People whose UC has not responded well to, stopped responding to, or who could not tolerate at least one standard medication (such as steroids, azathioprine, 6-mercaptopurine, or mesalazine-type medicines), and/or at least one advanced treatment such as a biologic, biosimilar, JAK inhibitor, or similar specialist therapy.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have been diagnosed with Crohn's disease, unclassified inflammatory bowel disease, or a liver condition called primary sclerosing cholangitis.
  • People who have already had bowel surgery or are expected to need bowel or abdominal surgery.
  • People who show signs of a serious bowel complication called toxic megacolon, or who have a narrowing in the colon that a bowel camera cannot pass through.
  • People who have type 1 diabetes, or type 2 diabetes that is treated with insulin.
  • People who have had a serious episode of very low blood sugar, or who do not notice the warning signs of low blood sugar, within the 6 months before screening.
  • People whose body weight has changed by more than 5% (either gained or lost) in the 3 months before screening.
  • 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 July 2026

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

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
26 June 2025
Est. completion
1 April 2028

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland Puerto Rico 🇷🇴 Romania 🇸🇰 Slovakia 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov