Phase 2 trial of DD01 in treating MASH completes enrollment
Overweight or obese adults with fatty liver disease recruited at US sites
D&D Pharmatech has finished enrolling a Phase 2 clinical trial of its experimental therapy DD01 in overweight or obese adults with metabolic dysfunction-associated steatohepatitis (MASH), a severe form of fatty liver disease.
“We are pleased to report that we have completed enrollment in our Phase 2 trial investigating DD01 in MASH patients,” Seulki Lee, PhD, president and CEO of D&D, said in a company press release.
Top-line data from the Phase 2 trial (NCT06410924), which started dosing patients in August, are expected by the close of June.
In earlier trial, DD01 reduced liver fat by 30% or more in MASLD patients
MASH is a severe form of metabolic dysfunction-associated steatotic liver disease (MASLD), a condition formerly known as nonalcoholic fatty liver disease and characterized by excessive fat accumulation in the liver. MASLD is associated with certain conditions, including obesity and type 2 diabetes — marked by high levels of blood sugar, or glucose.
In MASH, the buildup of fat leads to liver inflammation and scarring (fibrosis) that can set the stage for serious liver problems.
DD01, which is administered as an under-the-skin injection, aims to reduce liver fat buildup by simultaneously targeting receptors for the signaling molecules GLP-1 (glucagon-like peptide-1) and glucagon. GLP-1 receptors regulate metabolism and appetite, whereas glucagon receptors help to control fat levels in the liver. By targeting both pathways, the therapy is expected to potently reduce liver fat accumulation.
D&D believes that a potential benefit of DD01 — over similar therapies in development for MASH — is that it does not require an extended titration period. With titration, a treatment is started at a low dose that is slowly increased until the dose reaches therapeutic levels.
DD01 was granted fast track designation by the U.S. Food and Drug Administration (FDA) as a potential MASH treatment. The FDA gives this designation to speed the development of promising new treatments for serious diseases.
A previous Phase 1 trial (NCT04812262) of DD01 in overweight or obese adults with type 2 diabetes, with or without MASLD, showed promising early results. In MASLD patients, average liver fat content was reduced by more than 30%, and markers of glucose, blood fat, and liver damage also lowered. Treatment was associated with modest weight loss.
Phase 2 trial aiming for ‘robust’ drop in liver fat, glucose control with treatment
In the ongoing Phase 2 trial in the U.S., up to 68 overweight or obese adults with biopsy-confirmed MASH are being randomly assigned to an under-the-skin injection of either 40 mg of DD01 or a placebo, given once weekly for nearly a year (48 weeks).
The study’s main goal is to assess the percentage of patients with an at least 30% reduction in liver fat after 12 weeks (about three months). The trial, which is sponsored by D&D through its subsidiary Neuraly, also will be looking at changes in signs of liver fibrosis and glucose parameters, as well as safety-related outcomes.
“Based on clinical and preclinical studies completed to date, we expect this study to confirm best-in-class potential for DD01 in MASH with long-term treatment accompanied by three key beneficial effects — rapid and robust reductions in liver fat, glucose control, and weight loss leading to clinically significant rates of MASH resolution and fibrosis improvement without the need for the lengthy titration phase,” Lee said.
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