Clinical Study Report (Abbreviated) — GLPI103-102 (MAD / early efficacy)
| Field | Value |
|---|---|
| Document ID | CSR-102 |
| Version | 3.0 |
| Sponsor | Virtual Biopharma Inc. |
| Study No. | GLPI103-102 |
| Compound | GLPI-103 (GLP-1/APJ dual agonist) |
| Standard | ICH E3 (abbreviated report — early-phase) |
| Confidentiality | Confidential — portfolio use |
[MOCK — deep-knowledge assumption]Illustrative; consistent with IB-001 and REF-002.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical | Initial abbreviated CSR |
| 2.0 | 2026-06-30 | Clinical | Expanded to fuller ICH E3 structure (ethics, design, disposition, PK, efficacy, safety) |
| 3.0 | 2026-07-05 | Clinical | Submission-grade — added disposition, steady-state PK, and early-efficacy tables and a limitations section |
1. Synopsis
| Item | Description |
|---|---|
| Design | Phase 1b, randomized, double-blind, placebo-controlled, Multiple Ascending Dose (MAD) |
| Population | Overweight/obese adults with T2DM or prediabetes (patients, not healthy volunteers) |
| N | 40 (4 dose cohorts × 10; 8 active : 2 placebo) |
| Duration | Up to 12 weeks |
| Objectives | Safety/tolerability, multiple-dose PK; early efficacy (HbA1c, weight) and cardiometabolic biomarkers |
2. Ethics and Study Administration
Conducted per the Declaration of Helsinki, ICH E6(R3) GCP, and applicable regulations, with IRB/IEC approval and written informed consent. Cumulative safety was reviewed before each dose-cohort escalation [MOCK].
3. Rationale for Patient Population
Because the study evaluates multiple-dose early efficacy (HbA1c, weight), the population is patients with elevated baseline HbA1c — a healthy-volunteer MAD could not show glycemic reduction. This corrects a common design inconsistency and aligns the study with its readouts (REF-002 §3).
4. Investigational Plan
- Design: double-blind, placebo-controlled, parallel dose cohorts with repeat dosing and titration to manage gastrointestinal tolerability.
- Dose cohorts
[MOCK]: four ascending multiple-dose levels, each 10 subjects (8 active : 2 placebo), bracketing the projected therapeutic exposure. - Eligibility: adults with T2DM or prediabetes, BMI ≥27 kg/m², HbA1c in a defined range; standard GLP-1-class exclusions (MTC/MEN 2, pancreatitis history).
- Endpoints: safety/tolerability; steady-state PK; HbA1c and body-weight change; cardiometabolic biomarkers (NT-proBNP, hsCRP, HOMA-IR).
5. Study Subjects and Disposition [MOCK]
| Cohort (dose) | Active : PBO | Completed 12 wk | Discontinued |
|---|---|---|---|
| 1 (lowest) | 8 : 2 | 10 | 0 |
| 2 | 8 : 2 | 9 | 1 |
| 3 | 8 : 2 | 9 | 1 |
| 4 (highest) | 8 : 2 | 8 | 2 |
| Total | 32 : 8 | 36 | 4 |
The majority completed 12 weeks; the infrequent early discontinuations were for gastrointestinal tolerability at the higher cohorts. Baseline characteristics reflected an overweight/obese T2DM/prediabetes population (mean BMI ~31 kg/m²; HbA1c ~7.6%).
6. Pharmacokinetic Results [MOCK]
| PK parameter | Finding |
|---|---|
| Accumulation | modest, predictable (consistent with single-dose t½ ~130 h) |
| Time to steady state | within ~4–5 weeks of repeat dosing |
| Dose-exposure | exposure increased across the tested cohorts (approximately dose-proportional) |
| Immunogenicity | low-titre, non-neutralizing ADA; no PK impact |
Repeat dosing produced predictable accumulation reaching steady state within the dosing schedule, supporting the once-weekly (IV) / once-daily (oral) regimens (CLINPHARM-002).
7. Efficacy / Biomarker Results [MOCK]
| Endpoint (12 wk, top dose vs placebo) | Result |
|---|---|
| HbA1c CFB | ≈ −0.8% |
| Body-weight CFB | ≈ −3 kg |
| NT-proBNP / hsCRP | favourable change |
Effects were dose-dependent and supported the APJ-mediated mechanistic hypothesis and the Phase 2 dose range.
8. Safety Results [MOCK]
Dose-dependent, mostly mild–moderate gastrointestinal AEs managed by titration; no SAEs; no clinically significant laboratory, ECG, or vital-sign trends.
9. Discussion and Conclusions
Multiple doses were tolerable with titration and produced dose-dependent glycemic, weight, and cardiometabolic-biomarker effects, supporting Phase 2 dose-finding (GLPI103-201) and the doses carried into Phase 3.
10. Limitations
Small, short (12-week) early-phase study; efficacy signals are exploratory [MOCK] and were confirmed in the dose-finding (CSR-201) and pivotal (CSR-301) studies. PK conclusions are integrated in the clinical-pharmacology summary (M2.7.2; CLINPHARM-002).