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Also known as MORF-057, zotemtegrast
LY4268989 · 5 trials · 7 indications
The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%
* The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of \< or =1; and an endoscopy subscore of \< or =1 without friability.
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
| Arm | Type | Description |
|---|---|---|
| LY4268989 Study Dose 1 | EXPERIMENTAL | LY4268989 administered orally |
| LY4268989 Study Dose 2 | EXPERIMENTAL | LY4268989 administered orally |
| Placebo Study Dose | PLACEBO_COMPARATOR | Placebo administered orally |
| LY4268989 + Mirikizumab | EXPERIMENTAL | LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2. |
| Mirikizumab + LY4268989 Placebo | EXPERIMENTAL | Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2. |
| Group 1 (Part A) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 2 (Part A) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 3 (Part A) | PLACEBO_COMPARATOR | Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 4 (Part B) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 5 (Part B) | EXPERIMENTAL | Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period |
| Group 6 (Part B) | PLACEBO_COMPARATOR | Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period |
| MORF-057 200 mg BID | EXPERIMENTAL | Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks. |
| MORF-057 100 mg BID | EXPERIMENTAL | Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks. |
| MORF-057 100 mg QD-M | EXPERIMENTAL | Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received an oral dose of matching placebo for 12 weeks. |
| MORF-057 | EXPERIMENTAL | Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks. |
| Name | Type | Description |
|---|---|---|
| LY4268989 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Mirikizumab | DRUG | Administered IV then SC |
| LY4268989 Placebo | DRUG | Administered PO |
| MORF-057 | DRUG | MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. |
Inclusion Criteria: * Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC * Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by cen...
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LY4268989 is an investigational small molecule being developed for the treatment of moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease. It is not yet approved for any indication and is currently in Phase 2 clinical development.
LY4268989 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY. Lilly is the sponsor of the ongoing Phase 2 clinical trials evaluating the drug in ulcerative colitis.
LY4268989 is in Phase 2 clinical development. Two Phase 2 trials are currently recruiting participants, and no Phase 3 trials have been initiated. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
LY4268989 is being evaluated in two recruiting Phase 2 trials. NCT07415044 is a monotherapy study in adults with moderately to severely active ulcerative colitis, and NCT07186101 is testing LY4268989 co-administered with mirikizumab in adults with the same condition.
Yes, LY4268989 is also known as MORF-057. The two names refer to the same investigational small molecule. The alternative designation appears in the trial title for NCT07186101, which is evaluating LY4268989 (MORF-057) co-administered with mirikizumab in adults with ulcerative colitis.