The trial enrolled patients with HeFH and/or ASCVD, as well as people with multiple risk factors for ASCVD. Credit: OlgaKraemer / Shutterstock.

Dutch biotechnology company NewAmsterdam Pharma has finished enrolling subjects in a Phase III trial of a combination therapy for heterozygous familial hypercholesterolaemia (HeFH) and atherosclerotic cardiovascular disease (ASCVD).

The TANDEM clinical trial is evaluating a fixed-dose combination (FDC) of obicetrapib and ezetimibe in adults with HeFH and/or ASCVD.

It enrolled patients with one or both of these conditions, as well as people at risk of ASCVD due to their LDL-C levels being inadequately controlled by existing lipid-modifying therapies.

The randomised, double-blind trial enrolled a total of 407 patients who met the criteria, including a baseline LDL-C of a minimum of 70mg/dL.

Its primary goal is to assess the impact of the 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels from the baseline, against the effects of 10mg ezetimibe and 10mg obicetrapib as monotherapies, as well as against a placebo.

The study’s secondary objectives include assessing the effects of the FDC on other lipid parameters such as lipoprotein(a) (Lp(a)), apolipoprotein B (ApoB) and non-high-density lipoprotein cholesterol (non-HDL-C).

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The trial will also monitor the FDC regimen’s safety and tolerability in participants.

NewAmsterdam Pharma CEO Michael Davidson said: “Completing enrolment of the pivotal Phase III TANDEM trial marks an important step in our mission of advancing obicetrapib through late-stage clinical development and brings us closer to delivering a simple and convenient once-daily tablet to the millions of people suffering from dyslipidaemia.

“We look forward to sharing topline data from the TANDEM study in the first quarter of 2025.”

NewAmsterdam Pharma aims to develop treatments for metabolic diseases for which currently approved therapies have not been adequately or well-tolerated.

Last year, the company reported initial data from a Phase IIa clinical trial of obicetrapib for the treatment of early Alzheimer’s disease.

The drug was found to improve cholesterol metabolism and cognitive function in the brain by reducing 24 and 27-hydroxycholesterol levels.