zotemtegrast (LY4268989) / Schrodinger, Eli Lilly - LARVOL DELTA

A Study of LY4268989 (MORF 057) in Healthy Participants (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

Zotemtegrast: Primary completion of P2 EMERALD-3 trial (NCT07415044) for moderately to severely active ulcerative colitis in Jun 2030 (Eli Lilly) - Q2 2026 Results: Ccompletion of P2 EMERALD-3 trial for moderately to severely active ulcerative colitis in Jul 2031; Primary completion of P2 trial (NCT06226883) for moderately to severely active crohn's disease in Sep 2028; Completion of P2 trial for moderately to severely active crohn's disease in Jun 2030

Trial completion date • Trial primary completion date • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

TOPAZ-UC: LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: (clinicaltrials.gov) - P2 | N=252 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

TOPAZ-UC: LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: (clinicaltrials.gov) - P2 | N=252 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of LY4268989 (MORF 057) in Healthy Participants (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial

J6E-MC-KWAN: LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis: A Phase 2 Study (clinicaltrialsregister.eu) - P1/2 | N=75 | Recruiting | Sponsor: Eli Lilly & Co.

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

J6E-MC-KWAN: LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis: A Phase 2 Study (clinicaltrialsregister.eu) - P1/2 | N=75 | Recruiting | Sponsor: Eli Lilly & Co. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

LY4268989: Primary completion of P2 TOPAZ-UC trial (NCT07186101) for moderate to severe ulcerative colitis in May 2027 (Eli Lilly) - Q1 2026 Results: Completion of P2 trial for moderate to severe ulcerative colitis in Mar 2029

Trial completion date • Trial primary completion date • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EMERALD-3: LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=1431 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

GARNET: A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=385 | Recruiting | Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) | N=199 ➔ 385

Enrollment change • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

GARNET: A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=385 | Recruiting | Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) | N=164 ➔ 385

Enrollment change • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease

A Study of LY4268989 (MORF-057) in Healthy Participants (clinicaltrials.gov) - P1 | N=144 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed

Trial completion

J6E-MC-KWAN: LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis: A Phase 2 Study (clinicaltrialsregister.eu) - P1/2 | N=14 | Not yet recruiting | Sponsor: Eli Lilly & Co.

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

J6E-MC-KWAN: LY4268989 (MORF-057) Co-Administered with Mirikizumab in Adults with Moderately to Severely Active Ulcerative Colitis: A Phase 2 Study (clinicaltrialsregister.eu) - P1/2 | N=5 | Not yet recruiting | Sponsor: Eli Lilly & Co.

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

GARNET: A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=385 | Recruiting | Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) | Trial completion date: Aug 2028 ➔ Jun 2030 | Trial primary completion date: Nov 2026 ➔ Sep 2028

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

EMERALD-3: LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=1431 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

MORF-057: Completion of P2 EMERALD-2 trial (NCT05611671) for moderately to severely active ulcerative colitis in Aug 2026 (Eli Lilly) - Q4 2025 Results: Primary completion of P2 GARNET trial (NCT06226883) for moderately to severely active Crohn's disease in Nov 2026; Completion of P2 GARNET trial for moderately to severely active Crohn's disease in Aug 2028

Trial completion date • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

GARNET: A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=385 | Recruiting | Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) | N=210 ➔ 385

Enrollment change • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

MORF-057: Primary completion of P2 TOPAZ-UC trial (NCT07186101) for moderate to severe ulcerative colitis in May 2027 (Eli Lilly) - Q3 2025 Results: Completion of P2 trial for moderate to severe ulcerative colitis in Mar 2029

Trial completion date • Trial primary completion date • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of LY4268989 (MORF-057) in Healthy Participants (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Eli Lilly and Company | N=66 ➔ 114

Enrollment change

EFFICACY AND SAFETY OF MORF-057 THERAPY IN ADULTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: PHASE 2B EMERALD-2 STUDY RESULTS THROUGH WEEK 12 (UEGW 2025) - P2 | "Dose-dependent responses to MORF-057 were observed for clinical remission and hard-to-achieve endpoints such as HEMI at Week 12. The clinical remission rate with MORF-057 was numerically higher but did not achieve statistical significance vs. placebo, which showed higher-than-expected responses."

Clinical • P2b data • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Rare Diseases • Respiratory Diseases • Ulcerative Colitis

A Study of LY4268989 (MORF-057) in Healthy Participants (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date

MORF-057: Completion of P2 EMERALD-2 trial (NCT05611671) for moderately to severely active ulcerative colitis in Aug 2026 (Eli Lilly) - Q2 2025 Results: Primary completion of P2 GARNET trial (NCT06226883) for moderately to severely active Crohn's disease in Nov 2026; Completion of P2 GARNET trial for moderately to severely active Crohn's disease in Aug 2028

Trial completion date • Trial primary completion date • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

Study of MORF 057 to Evaluate Single and Multi Ascending Doses in Healthy Volunteers (clinicaltrials.gov) - P1 | N=67 | Completed | Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) | Phase classification: P1a ➔ P1

Phase classification

GARNET: A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) | Trial primary completion date: Jul 2026 ➔ Nov 2026

Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease