Eli Lilly and Company — Trulicity EMA EPAR public assessment report (EMEA/H/C/002825, 2014)
Eli Lilly and Company · 2014 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report details the 2014 regulatory assessment of Eli Lilly's Trulicity (dulaglutide) for type 2 diabetes, covering its initial application for combination therapy, subsequent inclusion of monotherapy, and the introduction of a 0.75 mg dose alongside the 1.5 mg. The extensive clinical development program, comprising 30 studies with over 4000 patients, demonstrated dulaglutide's efficacy in reducing HbA1c and body weight, often superior or non-inferior to comparators. Pharmacokinetic and pharmacodynamic properties, including dose-dependent effects on glucose, gastric emptying, and interactions, were thoroughly evaluated. Safety analyses highlighted common gastrointestinal adverse events (nausea, diarrhea, vomiting), but no significant increase in serious adverse events, mortality, or cardiovascular risk. The report confirms dulaglutide's quality, non-clinical profile, and suitability for once-weekly dosing in various treatment regimens.
Key findings — cited to the page
| Number of completed clinical studies | 30 | Trulicity · p.14 |
| Number of completed clinical pharmacology studies | 21 | Trulicity · p.14 |
| Number of completed Phase 2 studies | 4 | Trulicity · p.14 |
| Number of completed Phase 3 studies | 5 | Trulicity · p.14 |
| Number of subjects exposed to dulaglutide in completed clinical pharmacology trials | 680 | Trulicity · p.14 |
| Number of T2DM patients receiving dulaglutide in completed Phase 2 and Phase 3 studies | 4006 | Trulicity · p.14 |
| Number of T2DM patients receiving placebo in completed Phase 2 and Phase 3 studies | 703 | Trulicity · p.14 |
| Number of T2DM patients receiving active comparator in completed Phase 2 and Phase 3 studies | 1541 | Trulicity · p.14 |
| Number of ongoing studies | 10 | Trulicity · p.14 |
| Single dose range of dulaglutide administered | 0.1 mg to 12 mg | Trulicity · p.14 |
| Multiple dose range of dulaglutide administered | 0.05 mg to 8 mg once weekly for up to 6 weeks | Trulicity · p.14 |
| Marketing Authorisation application submission date | 27 September 2013 | Trulicity · EU · p.10 |
Source: Eli Lilly and Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →