NewAmsterdam Pharma (NAMS) said Wednesday that a phase 3 clinical trial assessing the fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg met all co-primary endpoints, including the one on reducing low-density lipoprotein cholesterol, or "bad cholesterol."
The combination was evaluated in adult patients with heterozygous familial hypercholesterolemia and/or atherosclerotic cardiovascular disease or multiple ASCVD risk factors, whose bad cholesterol is not adequately controlled even though they're on maximally tolerated lipid reduction therapy, the company said.
At day 84, the combination was observed to cut bad cholesterol by about 50% compared with placebo, according to NewAmsterdam.
The combination was also observed to be well-tolerated, having safety results comparable with placebo, the company said.
The company said the data will support regulatory filings for the combination worldwide.
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