Module 5.2 — Tabular Listing of All Clinical Studies
📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. Module 5.2 — the tabular listing of all clinical studies in the program.
Why it exists. A single table indexes every clinical study (phase, design, population, status, location in the dossier), so a reviewer can see the whole clinical program at a glance.
How it is produced here. It contains no new data. It is a distillation — it gathers, summarizes, and cross-references the underlying study reports and datasets into the shorter form a regulator reads first.
Format & governing standard. ICH M4E(R2) §5.2
Module 5.2 — Tabular Listing of All Clinical Studies
| Field | Value |
|---|---|
| Document ID | M52 |
| Version | 2.0 |
| Compound | GLPI-103 (GLP-1/APJ dual agonist) |
| Sponsor | Virtual Biopharma Inc. |
| Standard | ICH M4E(R2) §5.2 |
| Confidentiality | Confidential — portfolio use |
Change History
| Version | Date | Author | Summary of Change |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical | Initial listing |
| 2.0 | 2026-07-05 | Clinical | Expanded — added the clinical-pharmacology / biopharmaceutic study reports and the CTD 5.3.x location column |
1. Clinical Efficacy/Safety and Early-Phase Studies
| Study | Phase | CTD | Design | Population | N | Duration | Primary endpoint | Report |
|---|---|---|---|---|---|---|---|---|
| GLPI103-101 | 1 (FIH) | 5.3.5.2 | R, DB, PBO-controlled, SAD | Healthy volunteers | 40 | Single dose | Safety, tolerability, PK | CSR-101 |
| GLPI103-102 | 1b | 5.3.5.2 | R, DB, PBO-controlled, MAD | Overweight/obese T2DM/prediabetes | 40 | ≤12 wk | Safety + early efficacy | CSR-102 |
| GLPI103-201 | 2 | 5.3.5.2 | R, DB, PBO-controlled, dose-finding | T2DM on metformin | 240 | 24 wk | HbA1c change (dose–response) | CSR-201 |
| GLPI103-301 | 3 (pivotal) | 5.3.5.1 | R, DB, double-dummy, active-controlled | T2DM inadequately controlled on metformin | 900 planned / 900 randomized | 52 wk | HbA1c change at Week 52 (superiority vs semaglutide) | CSR-301 |
2. Clinical-Pharmacology and Biopharmaceutic Study Reports
| Study type | CTD | Objective | Report |
|---|---|---|---|
| Biopharmaceutics (absolute/relative BA, food effect, IV↔oral bridging) | 5.3.1.1 | oral bioavailability & dosing conditions | CLINPHARM-001 |
| Bioanalytical method validation (PK LC–MS/MS; ADA assay) | 5.3.1.4 | assay validation (ICH M10) | BIOANALYTICAL-001 |
| Human PK — SAD/MAD, population PK & exposure–response | 5.3.3.1/5.3.3.3 | PK characterization, E–R | CLINPHARM-002 |
| Intrinsic-factor PK — hepatic & renal impairment | 5.3.3.3 | dose-adjustment assessment | CLINPHARM-002 §4 |
| Drug–drug-interaction studies (CYP cocktail, oral contraceptive, metformin) | 5.3.3.4 | interaction potential | CLINPHARM-002 §5 |
| Human PD (biomarkers) & cardiac safety (thorough-QT / C–QTc) | 5.3.4 | PD engagement; E14 QT | CLINPHARM-003 |
| Immunogenicity (integrated) | 5.3.3/2.7.2 | ADA incidence/impact | IMMUNO-001 |
3. Integrated Analyses and Appendices
| Item | CTD | Report |
|---|---|---|
| Integrated Summary of Efficacy | 5.3.5.3 | ISE-301 |
| Integrated Summary of Safety | 5.3.5.3 | ISS-301 |
| Patient narratives (deaths/SAEs/AE-discontinuations) | 5.3.5.1 (CSR-301 App. 16.3) | CSR-301-N |
| Datasets & reviewer's guides (define.xml, SDRG, ADRG, ARM, validation) | 5.3 | DEF-301 / ARM-301 |
R = randomized; DB = double-blind; PBO = placebo. Parameters per REF-002. Pivotal results (CSR-301): GLPI-103 IV −0.68% / Oral −0.34% vs oral semaglutide on HbA1c CFB at Week 52 (both p<0.001). Clinical-pharmacology and biopharmaceutic content is deep-knowledge [MOCK]; the Phase-3 efficacy/safety thread is data-anchored and reconciled.
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