Module 2.7.6 — Synopses of Individual Studies
| Field | Value |
|---|---|
| Document ID | M276 |
| Version | 1.0 |
| Compound | GLPI-103 (GLP-1/APJ dual agonist) |
| Standard | ICH M4E(R2) §2.7.6 |
| Confidentiality | Confidential |
One-page synopsis per clinical study. Pivotal figures trace to
outputs/(reconciled); early-phase[MOCK].
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical | Initial synopses |
GLPI103-101 (Phase 1, SAD) — CSR-101
Randomized, DB, placebo-controlled single ascending dose in 40 healthy volunteers (5 cohorts × 8; 6:2). Objectives: safety, tolerability, PK; PD (plasma apelin). Result [MOCK]: no dose-limiting toxicity; ~dose-proportional PK; long half-life supporting QW dosing.
GLPI103-102 (Phase 1b, MAD) — CSR-102
Randomized, DB, placebo-controlled multiple ascending dose, ≤12 weeks, in 40 overweight/obese adults with T2DM/prediabetes (4 cohorts × 10; 8:2). Result [MOCK]: titration-manageable GI AEs; dose-dependent HbA1c (~−0.8%) and weight (~−3 kg); favourable NT-proBNP/hsCRP.
GLPI103-201 (Phase 2, dose-finding) — CSR-201
Randomized, DB, placebo-controlled, 4 arms (PBO + low/med/high), 24 weeks, 240 T2DM on metformin. Primary: HbA1c CFB. Result [MOCK]: monotonic dose–response; dose-dependent weight loss; GI AEs dose-related. Supported Phase 3 doses (Gate-3 decision; PM-002).
GLPI103-301 (Phase 3, pivotal) — CSR-301
Randomized, DB, double-dummy, active-controlled (vs oral semaglutide), 1:1:1, 52 weeks, 900 randomized to target (IV 300 / Oral 301 / Sema 299; 1,700 screened) T2DM inadequately controlled on metformin. Primary: HbA1c CFB at Week 52.
- Result: superiority — IV −0.68% (95% CI −0.81, −0.55; p<0.001), Oral −0.34% (−0.47, −0.21; p<0.001); LS means −2.57 / −2.23 / −1.89.
- Secondary: weight −14.5 / −10.3 / −7.6 kg; ≥10% weight loss 100.0 / 83.0 / 44.2%; HbA1c <7.0% 94.1 / 94.6 / 86.2%.
- Safety: any TEAE 75.7 / 67.8 / 72.2%; nausea higher with IV (32.3% vs 21.4%, p=0.003); 10 SAEs, 2 deaths; discontinuation 9.3%.
- Conclusion: superior efficacy with a class-consistent, manageable safety profile.