Research Highlights:
- In a small, short-term, Phase 2 clinical trial in adults, a first-of-its-kind medication reduced triglyceride levels in most patients by more than 60%. Called DR10624, the medication activates three different receptors linked to triglycerides: FGF21, glucagon and GLP-1 receptors.
- In addition, patients treated with DR10624 had a 63% reduction in liver fat, which is important because many people with severe hypertriglyceridemia, levels between 500-2,000 mg/dL, also have excess fat in the liver, leading to liver damage.
- The results suggest that DR10624 may be an innovative and promising option for people with severe hypertriglyceridemia, which can be challenging to treat with current medications.
- Note: The study featured in this news release is a research abstract. Abstracts presented at American Heart Association's scientific meetings are not peer-reviewed, and the findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal.
NEW ORLEANS, Nov. 8, 2025 — In a small, short duration trial (12 weeks), a new medication called DR10624 reduced triglyceride levels in most patients with severe hypertriglyceridemia by more than 60%, according to a preliminary late-breaking science presentation today at the American Heart Association's Scientific Sessions 2025. The meeting, Nov. 7-10, in New Orleans, is a premier global exchange of the latest scientific advancements, research and evidence-based clinical practice updates in cardiovascular science.
The study was designed to test whether DR10624 could safely and effectively lower very high levels of lipids in the blood or triglycerides in people with severe hypertriglyceridemia (500-2,000 mg/dL), who may be at high risk of cardiovascular disease or pancreatitis due to elevated triglycerides. High triglyceride levels combined with high LDL cholesterol or low HDL cholesterol are linked to fatty buildup in the artery walls, which increases the risk of heart attack and stroke, as well as other serious health problems including inflammation of the pancreas. In addition, high triglycerides often lead to excess fat in the liver, also known as metabolic dysfunction-associated steatotic liver disease (MASLD; formerly called non-alcoholic fatty liver disease (NAFLD)), which can cause metabolic dysfunction-associated steatohepatitis (MASH) (formerly called nonalcoholic steatohepatitis (NASH)). There are no standard therapeutic treatments for MASLD, while there is only one FDA-approved therapy for MASH. Current treatments for high triglyceride levels include fibrates, concentrated omega-3 fatty acids (available by prescription only) or statins. However, they don't always provide sufficient triglyceride lowering and/or may have limited effects on liver fat.
DR10624 activates three different receptors in the body, FGF21, glucagon and GLP-1 receptors, all of which help to control how the body processes fats and sugars. This is the first investigational medication of its kind to target all three receptors at once.
"DR10624 could become a game-changer for patients with severe hypertriglyceridemia by reducing long-term risks of pancreatitis, as well as conditions like MASLD and cardiovascular disease," said lead study author Jianping Li, M.D., Ph.D., a professor and chief in the Institute of Cardiology Disease at Peking University First Hospital in China. "Severe hypertriglyceridemia is often difficult to manage with existing treatments, so access to more treatment choices are crucial for improving patient outcomes as well as quality of life."
The study included 79 adults with very high triglyceride levels (between 500 and 2000 mg/dL) randomly assigned to receive either a weekly, subcutaneous injection of DR10624 at one of three doses (12.5 mg, 25 mg or 50 mg titration) or a placebo for 12 weeks. The study was double-blind, meaning neither the participants nor the researchers knew who was being treated with DR10624 versus the placebo.
After 12 weeks:
- The group of patients who received the 12.5 mg dose of DR10624 showed a 74.5% reduction in triglycerides; the group that received the 25 mg dose had a 66.2% reduction; and the group that received the 50 mg titration dose had a 68.9% reduction. The group that received the placebo had an 8.0% reduction in triglycerides.
- Of the patients receiving DR10624, 89.5% achieved triglyceride levels below 500 mg/dL, compared to 25.0% of patients receiving a placebo.
- Additionally, 78.5% of DR10624 patients had a greater than 50% reduction in triglycerides since enrollment in the study, compared to only 5% of patients receiving the placebo achieving at least a 50% reduction in triglycerides.
- Patients in the group treated with DR10624 had significant improvements in other important lipid measures, including total cholesterol, high-density lipoprotein cholesterol, non-HDL cholesterol and triglyceride-rich lipoprotein cholesterol.
- Patients treated with DR10624 had a 63.5% reduction in liver fat. In contrast, the placebo group showed only an 8.4% reduction in liver fat.
- The most common side effects were gastrointestinal (GI) issues, such as nausea or stomach upset, which are common with medications that target GLP-1 receptors. While these side effects were generally mild, GI symptoms affect some patients more significantly and can be more challenging if the treatment is needed long-term. In future studies, gradually increasing the dose level of DR10624 over several weeks may help to ease some symptoms.
"Patients with severe hypertriglyceridemia face limited treatment options, especially if lifestyle changes alone are not enough to manage their triglyceride levels," said Li. "DR10624 could be an effective alternative, especially if other medications have not been successful."
The researchers said the next steps in clinical research would involve longer-term trials with more participants and a more diverse study population to assess the safety and efficacy of DR10624.
"Given that DR10624 targets multiple metabolic pathways simultaneously, it could be a strong candidate for combination therapies with other medications," said Li. "For example, pairing it with glucose-lowering medications, such as SGLT2 inhibitors or DPP-4 inhibitors, might improve overall metabolic control in patients with other conditions, such as Type 2 diabetes, obesity and/or cardiovascular disease."
Study details, background and design:
- The study included 79 adults with an average age of 46 years. Of the participants, 89% were men, and 100% self-reported being of Asian ancestry (97.5% were Han Chinese).
- 179 participants were screened at 35 health care centers in Mainland China between September 29, 2024 and March 26, 2025, and narrowed down to the final group of 79 for the 12-week trial.
- All participants had severe hypertriglyceridemia—levels between 500-2000 mg/dL.
- Approximately 30% of the participants were taking triglyceride-lowering medications throughout the study.
- There was no statistically significant difference among participants in the DR10624 treatment group taking triglyceride-lowering medications vs. those not taking any triglyceride-lowering medications.
Triglycerides are a type of fat (lipid) found in the blood, and high triglyceride levels combined with high LDL cholesterol or low HDL cholesterol are linked to fatty buildup in the artery walls, which increases the risk of heart attack and stroke.
The study had several limitations, including the short duration of the treatment period of only 12 weeks. More research is needed to understand if DR10624 continues to work well with a longer duration of treatment and if there are any delayed side effects that may emerge over time. The number of patients in the trial was small, and the study was only conducted in Mainland China; therefore, the findings cannot be generalized to the public. Additional research is needed that includes more people and people in diverse parts of the world in order to confirm these findings.
Another limitation to note is that DR10624 was not directly compared to any other approved triglyceride-lowering medications, such as fibrates or concentrated omega-3 fatty acids. The researchers do not know yet whether DR10624 is statistically more effective or safer than existing treatments.
Co-authors, disclosures and funding sources are listed in the manuscript.
Statements and conclusions of studies that are presented at the American Heart Association's scientific meetings are solely those of the study authors and do not necessarily reflect the Association's policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. Abstracts presented at the Association's scientific meetings are not peer-reviewed, rather, they are curated by independent review panels and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting. The findings are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal.
