Module 4 — Nonclinical Study Reports (Index & Stubs) — GLPI-103
| Field | Value |
|---|---|
| Document ID | M4 |
| Version | 1.0 |
| Compound | GLPI-103 (GLP-1/APJ dual agonist) |
| Standard | ICH M4S; CTD §4.2; SEND (planned) |
| Confidentiality | Confidential — portfolio use |
[MOCK — deep-knowledge assumption]No nonclinical wet-lab data are generated. This is the §4.2 index; full real-form study reports are in M4-2.1 (pharmacology), M4-2.2 (PK/ADME), and M4-2.3 (toxicology, incl. the pivotal 26-week rat study in full). Interpretive content in M2.4; tabulated summaries in M2.6. Nonclinical data would be standardized to SEND.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Nonclinical | Initial M4 index/stubs |
4.2.1 Pharmacology
| Report | Type | Key result (illustrative) |
|---|---|---|
| PD-IVT-01 | In-vitro potency/selectivity | GLP-1R EC₅₀ 14 pM; APJ EC₅₀ 48 pM; inactive at GIP/glucagon R |
| PD-PRIM-01 | Primary PD (db/db, DIO in vivo) | HbA1c −1.8% vs −1.1% comparator; weight −18%; +58% clamp GIR |
| PD-SEC-01 | Secondary PD / off-target panel | No significant off-target hits |
| PD-SAFP-01 | Safety pharmacology (S7A/S7B) | hERG IC₅₀ >30 µM (>1000×); no QT/CNS/respiratory liability |
4.2.2 Pharmacokinetics (S3A)
| Report | Type | Key result |
|---|---|---|
| PK-ADME-01 | ADME (rat/monkey) | Dose-proportional; long t½; proteolytic catabolism |
| PK-IMM-01 | Immunogenicity | Low-titer, non-neutralizing ADA |
4.2.3 Toxicology (S-series)
| Report | Type | Key result |
|---|---|---|
| TOX-RD-01/02 | Repeat-dose (26-wk rat / 39-wk monkey) | Reversible exaggerated-pharmacology; NOAEL ≈25× (rat)/20× (monkey) |
| TOX-GEN-01 | Genotoxicity battery (S2) | Negative |
| TOX-CARC-01 | Carcinogenicity (S1) | Rodent-specific thyroid C-cell finding; human-relevance assessed (QA-003 ISS-012) |
| TOX-REPRO-01 | Reproductive/developmental (S5) | Maternal-toxicity-limited; no unique teratogenicity |
Full study reports (with GLP statements and SEND datasets) would populate each stub in an actual submission. Conclusions are integrated in M2.4 §5.