hepalatide (L47) / Shanghai HEP Pharma - LARVOL DELTA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Phase III Clinical Trial of Hepalatide for Injection in Patients with Chronic Hepatitis D (ChiCTR) - P3 | N=150 | Not yet recruiting | Sponsor: Jilin University First Hospital; Shanghai HEP Pharmaceutical Co., Ltd.

New P3 trial • Inflammation

Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.

New P3 trial • Inflammation

L47-HD-MN: A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2029 ➔ Jul 2026 | Trial primary completion date: Dec 2025 ➔ May 2026

Enrollment closed • Trial completion date • Trial primary completion date • Inflammation

ENTRY INHIBITION COMBINED WITH IFN IMMUNOTHERAPY ACHIEVED UNDETECTABLE INTRAHEPATIC HBV CCCDNA: RESULTS: FROM A PHASE II RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL (AASLD 2025) - P2 | "PEG-IFN may promote cccDNA degradation via immune activation, while entry inhibitors block its replenishment by preventing new HBV infection. The combination of hepalatide and PEG-IFN demonstrated measurable intrahepatic cccDNA reduction, supporting a potential strategy for depleting the HBV reservoir. These findings warrant validation in larger studies to further explore their potential contribution to achieving a sterilizing cure for CHB."

Clinical • IO biomarker • P2 data • Hepatitis B • Hepatitis C • Hepatology • Immune Modulation • Immunology • Infectious Disease • Inflammation • IFNA1

HBV ENTRY INHIBITOR REVERSES RESISTANCE TO PEGYLATED INTERFERON IN HBEAG-POSITIVE CHRONIC HEPATITIS B PATIENTS: RESULTS: FROM A PHASE II MULTICENTER DOUBLE-BLIND RANDOMIZED TRIAL OF HEPALATIDE (AASLD 2025) - P2 | "The addition of hepalatide to PEG-IFN therapy effectively reversed resistance in HBeAg-positive CHB patients, leading to improved antiviral efficacy. These results support further evaluation of this combination strategy to enhance long-term interferon-based treatment outcomes."

Clinical • P2 data • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • IFNA1

Entry inhibitor Hepalatide combined with pegylated interferon-alpha 2a therapy resulted in cccDNA clearance in CHB patients: a phase II randomised, double-blind, placebo-controlled trial (EASL 2025) - P2 | "The combination therapy in the present trial may alter the balance of the HBV reservoir by blocking cccDNA replenishment through inhibiting HBV entry via HLT and accelerating cccDNA decay via PEG-IFN. This strategy provides great potential to achieve a sterilising cure for patients with CHB."

Clinical • P2 data • Fibrosis • Hepatitis B • Hepatitis C • Hepatology • Immunology • Inflammation

L47-HD-MN: A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Inflammation

L47-HD-MN: A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Trial completion date: Sep 2029 ➔ Dec 2029 | Initiation date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Dec 2025

Trial completion date • Trial initiation date • Trial primary completion date • Hepatology • Inflammation

L47-HD-MN: A Clinical Trial of Hepalatide for Injection in Patients With Chronic Hepatitis D (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.

New P2 trial • Hepatology • Inflammation

A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients (clinicaltrials.gov) - P2 | N=8 | Completed | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | N=30 ➔ 8

Enrollment change • Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Study of Hepalatide in Chronic Hepatitis D(CHD) Patients (clinicaltrials.gov) - P2 | N=23 | Completed | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Hepatology • Infectious Disease • Inflammation

A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=96 | Completed | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Access the Efficacy in Type 2 Diabetes Mellitus on Stable Metformin (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | N=36 ➔ 0 | Trial completion date: Dec 2023 ➔ Dec 2025 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial completion date • Trial withdrawal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Study of Hepalatide in Chronic Hepatitis D(CHD) Patients (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Phase classification: P2a ➔ P2 | Initiation date: Jun 2023 ➔ Oct 2023

Enrollment open • Phase classification • Trial initiation date • Hepatology • Infectious Disease • Inflammation

The safety and efficacy of hepalatide (L47) treatment combined with pegylated interferon-alpha 2a in patients with chronic hepatitis B: the preliminary data from a double-blind, RCT phase II trial (EASL-ILC 2023) - "Though the study is not complete, the preliminary data show a good safety and well tolerance of L47 treatment in combination with Peg-IFN. Importantly, the HBV DNA levels were declined rapidly in a L47 dose-dependent manner, highlighting its therapeutic potential in anti-HBV treatment. Figure: Fig."

Clinical • P2 data • Fatigue • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Neutropenia • Pain

Phase IIa Clinical Trial of Hepalatide in CHD Patients (clinicaltrials.gov) - P2a | N=24 | Not yet recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.

New P2a trial • Hepatology • Infectious Disease • Inflammation

A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Trial completion date: Jun 2023 ➔ Oct 2023 | Trial primary completion date: Dec 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Tumor

A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2022 ➔ Aug 2022 | Trial primary completion date: Feb 2024 ➔ Aug 2024

Enrollment open • Trial initiation date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.

New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Phase II Study of Hepalatide in Subjects With HBeAg-positive Chronic Hepatitis B (clinicaltrials.gov) - P2; N=96; Recruiting; Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.; Enrolling by invitation ➔ Recruiting

Clinical • Enrollment status • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of TAF in Combination With PEG-IFN and Hepalatide in Subjects With Chronic Hepatitis B (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.

Clinical • Combination therapy • New P2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Phase II Study of Hepalatide in Subjects With HBeAg-positive Chronic Hepatitis B (clinicaltrials.gov) - P2; N=96; Enrolling by invitation; Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.; Recruiting ➔ Enrolling by invitation; Trial completion date: Dec 2022 ➔ Jun 2023; Trial primary completion date: Jun 2022 ➔ Dec 2022

Clinical • Enrollment status • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Phase II Study of Hepalatide in Subjects With HBeAg-positive Chronic Hepatitis B (clinicaltrials.gov) - P2; N=96; Recruiting; Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Access the Efficacy in Type 2 Diabetes Mellitus on Stable Metformin (clinicaltrials.gov) - P1/2; N=36; Not yet recruiting; Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.; Trial completion date: Dec 2022 ➔ Dec 2023; Initiation date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase II Study of Hepalatide in Subjects With HBeAg-positive Chronic Hepatitis B (clinicaltrials.gov) - P2; N=96; Not yet recruiting; Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.; Trial completion date: Mar 2022 ➔ Dec 2022; Initiation date: Dec 2020 ➔ Apr 2021; Trial primary completion date: Aug 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease