I6T-MC-AMCD
Research type
Research Study
Full title
A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered with Tirzepatide in Adult Participants with Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight.
IRAS ID
1011902
Contact name
Niamh O Shea
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
Study, I6T-MC-AMCD (AMCD), aims to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active Ulcerative Colitis (UC) and obesity, or overweight and in the presence of at least 1 weight-related condition, including
• hypertension
• type 2 diabetes mellitus
• dyslipidemia
• obstructive sleep apnoea, or
• cardiovascular disease.
The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to
• decrease or disappearance of UC symptoms, and
• loss of at least one-tenth of the overall body weight.
Study details include:
• The study duration will be up to 61 weeks.
• The treatment duration will be up to 52 weeks.
• The visit frequency will be every 4 weeks during the treatment period.
Between Week 28 and Week 48, some of the visits will be conducted by telephone.
Approximately 350 participants will be randomly assigned to mirikizumab and placebo or mirikizumab and tirzepatide used concomitantly, with a 50% chance of receiving mirikizumab and placebo and a 50% chance of receiving mirikizumab and tirzepatide.REC name
London - Brent Research Ethics Committee
REC reference
25/LO/0423
Date of REC Opinion
10 Jul 2025
REC opinion
Further Information Favourable Opinion