MK-7262 / Jiangsu Hengrui Pharma, Merck (MSD) - LARVOL DELTA

A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003) (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion

Oral HRS-5346, a novel small molecule lipoprotein(a) inhibitor, in adults at high cardiovascular risk with elevated lipoprotein(a): a phase 2, randomized, double-blind study (ESC 2026) - No abstract available

Clinical • Late-breaking abstract • P2 data • Cardiovascular

Study of Oral HRS-5346 in Adult Patients With Elevated Lipoprotein(a) and High Risk of Cardiovascular Events (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Cardiovascular

Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial

A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003) (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004) (clinicaltrials.gov) - P2 | N=750 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy

A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003) (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial

A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004) (clinicaltrials.gov) - P2 | N=750 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

Monotherapy • New P2 trial

A Study of HRS-5346 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular

A Study of HRS-5346 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular

HRS-5346-101: Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=71 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion

Merck Enters Exclusive License Agreement for HRS-5346, an Investigational Oral Lipoprotein(a) Inhibitor, for Cardiovascular Disease from Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Merck (MSD) Press Release) - "Merck...and Jiangsu Hengrui Pharmaceuticals Co., Ltd...announced that the companies have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor currently being evaluated in a Phase 2 clinical trial in China....Under the agreement, Hengrui Pharma has granted Merck exclusive rights to develop, manufacture and commercialize HRS-5346 worldwide, excluding Greater China region. Hengrui Pharma will receive an upfront payment of $200 million and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $1.77 billion, as well as royalties on net sales of HRS-5346, if approved....Closing of the proposed transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the second quarter of 2025."

Licensing / partnership • Cardiovascular

A Study of HRS-5346 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular

A Study of HRS-5346 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Cardiovascular

HRS-5346-101: Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=71 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed

HRS-5346-101: Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial