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American Diabetes Association Highlights New Drug Therapy Innovations for Obese Patients

American Diabetes Association Highlights New Drug Therapy Innovations for Obese Patients

 


New drug demonstrates effectiveness in reducing once-weekly medication, controlling blood sugar and blood pressure

ORLANDO, Fla., June 23, 2024 /PRNewswire/ — Results from three studies provide new data on emerging trends in pharmacotherapy for the treatment of obesity, including new insights on GLP-1 (glucagon-like peptide-1) receptor agonists. The data were presented as a late-breaking poster and an oral presentation, respectively, at the American Diabetes Association's (ADA) 84th Scientific Session in Orlando, Florida.

These studies are part of a growing body of research and development driven by interest in new GLP-1 drugs and concerns about obesity. Obesity affects approximately 125 million people in the United States, including 41.9% of adults and 19.7% of children and adolescents. In particular, 90% of people with diabetes are overweight or obese. Weight gain is a major concern for doctors and patients who want to better control blood sugar, blood pressure, and lipids in diabetic patients.

“Over the past few years, we have seen new research have a profound impact in solving the twin health crises we face: obesity and diabetes,” said ADA Chief Scientific and Medical Officer Dr. Robert Gabbay. “The research being presented at this year's annual meeting shows great potential to bring new solutions and treatment options to patients around the world living with type 2 diabetes and obesity.”

Drug treatment for obesity effectively reduces weight and blood pressure

HRS9531 is a dual GLP-1/GIP (glucose-dependent insulinotropic polypeptide) receptor agonist that offers a treatment option for patients who are overweight or obese and have type 2 diabetes. This Phase 2 study evaluated the efficacy and safety of HRS9531 in obese adults without diabetes. The study found that HRS9531 effectively reduced body weight, blood pressure, blood glucose, and triglycerides with a favorable safety profile.

A double-blind, randomized, placebo-controlled Phase 2 study was conducted in 249 Chinese adults with a BMI of 28-40 kg/m. Participants were randomized into five groups to receive weekly subcutaneous injections of HRS9531 (1.0 mg, 3.0 mg, 4.5 mg, 6.0 mg) or placebo for 24 weeks. The primary endpoint was percent change in body weight at week 24.

Patients receiving HRS9531 achieved greater weight loss compared to those receiving placebo. At the end of the 24-week intervention, participants in the 1.0 mg, 3.0 mg, 4.5 mg, and 6.0 mg HRS9531 groups achieved weight loss of 5.4%, 13.4%, 14.0%, and 16.8%, respectively, compared with a 0.1% reduction in the placebo group. Additionally, the percentage of participants achieving a 5% weight loss was 52.0%, 88.2%, 92.0%, 91.8%, and 10.2%, respectively. Most adverse events (AEs) were mild or moderate, with the most common AEs being nausea, diarrhea, decreased appetite, and vomiting, which occurred primarily during dose escalation. The overall safety and tolerability profile of HRS9531 is consistent with other GLP-1 agonists.

“Obese people are at higher risk of developing chronic diseases such as type 2 diabetes and cardiovascular disease. Losing weight can significantly reduce the risk of these diseases,” said Xiaoying Li, MD, professor and director of the Department of Endocrinology and Metabolism at Zhongshan Hospital of Fudan University in China and senior author of the paper. “Diet and exercise interventions alone are often not enough, so we are pleased that this could be a promising treatment for weight management, potentially improving overall health and significantly reducing the societal burden of obesity.”

The study authors note that a phase 3 study of HRS9531 in overweight or obese Chinese people is already underway, with multi-site studies planned.

An drug called pembidutide has been shown to increase the average weight loss rate in overweight and obese patients by 15.6%.

The Phase 2 MOMENTUM trial has shown promising results evaluating whether Altimmune's investigational GLP-1/glucagon dual receptor agonist pembidutide, in development to treat a liver disease called obesity- and metabolic dysfunction-associated steatohepatitis (MASH), can help overweight and obese individuals lose weight. The study showed encouraging results with significant reductions in body weight and serum lipids over 48 weeks of treatment. Additionally, body composition analysis demonstrated best-in-class preservation of lean body mass.

This phase 2, randomized, placebo-controlled trial enrolled 391 non-diabetic overweight or obese subjects who received three dose levels of pemvidutide (1.2, 1.8, or 2.4 mg) or a placebo weekly for 48 weeks. Neither researchers nor subjects knew what treatment they were receiving.

After 48 weeks, subjects receiving the highest dose of pemvidutide had lost an average of 15.6% of their body weight, and the treatment appeared to be safe and well tolerated. Several potential benefits of this weight loss regimen were identified, including a simple dosing regimen and a significant reduction in the amount of lipids (such as cholesterol and triglycerides) in the blood and liver, which may help reduce the risk of cardiovascular disease. Additionally, results from a body composition substudy were presented, showing best-in-class retention of lean body mass; only 21.9% was lean, with 78.1% of the weight loss coming from fat. Preservation of lean body mass, which primarily includes muscle, is thought to be essential for maintaining physical function and reducing fracture risk.

“Obesity and its associated comorbidities are a major and growing health issue. Effectively managing each patient's weight and addressing other obesity-related diseases they may have will require multiple treatment approaches,” said lead researcher Louis J. Aronne, MD, FACP, DABOM, of Weill Cornell Medicine in New York City, NY. “These results demonstrate that the use of pemvidutide can have an important impact on the quality of weight loss and the cardiometabolic complications associated with obesity. Additionally, as the focus shifts to long-term weight management, preserving lean body mass will be critical to patient care.”

The study authors are preparing a larger Phase 3 registrational trial aimed at demonstrating the safety and clinical benefit of pembidutide in weight management. Additionally, because obesity can lead to the accumulation of excess liver fat and MASH, pembidutide is also being studied in patients with this disease.

Retatortide improves insulin's ability to lower blood sugar in people with type 2 diabetes

Biomarker analysis can help understand the disease and identify specific therapeutic targets. The new study evaluated biomarkers to observe how treatment with retatortide affects pancreatic beta cells, which produce insulin, as well as biomarkers related to the body's ability to lower blood sugar levels in response to insulin. The study looked at exploratory biomarker studies in the Phase 2 clinical trial to further understand how retatortide works at a molecular level, further helping to explain the key results.

Studies have shown that treatment with retatortide increases markers of healthy functioning of insulin-producing beta cells (HOMA2-B) and the ability of insulin to lower blood sugar (adiponectin). Retatortide also appears to reduce markers of stress on insulin-producing cells, as assessed by measuring premature insulin (proinsulin) and reducing markers of insulin resistance (HOMA2-IR).

“This study is important because many people with type 2 diabetes take multiple diabetes medications to reach their blood sugar goals, and new medications that could simplify their treatment plans are needed,” said Melissa K. Thomas, MD, vice president of diabetes and metabolism research at Lilly Research Institute in Indianapolis, Ind., and one of the researchers who conducted the study. “We are encouraged that our clinical trial lowered blood sugar levels and improved response to insulin in patients with obesity or type 2 diabetes.”

There are several ongoing Phase 3 clinical trials studying retatortide in patients with type 2 diabetes or obese patients without type 2 diabetes, including the TRIUMPH and TRANSCEND Phase 3 trials.

Research presentation details:

Dr. Zeng will present his findings in the following late-breaking poster sessions:

Late-Breaking Poster: Efficacy and Safety Phase 2 Study of HRS9531, a Novel Dual GLP-1/GIP Receptor Agonist, in Obese Adults was presented on Saturday, June 22, 2024 at 12:30 PM EDT.

Dr. Aronne will present his findings in an upcoming presentation session.

Oral Presentation – Examining the Potential of Incretin-Based Therapeutics in Obesity: A 48-Week, Placebo-Controlled Phase 2 (MOMENTUM) Study of the GLP-1/Glucagon Dual Receptor Agonist Pemvidutide in Overweight or Obese Subjects Presented on Sunday, June 23, 2024 at 1:45 PM EDT

Dr. Thomas will present his findings during the following oral presentation sessions:

Oral Presentation – Examining the potential of incretin-based therapies in obesity: Retatortide, a GIP, GLP-1, and glucagon receptor agonist, improves markers of pancreatic beta cell function and insulin sensitivity. Presentation time: Sunday, June 23, 2024, 2:45 PM EDT.

About ADA Scientific Sessions The ADA's 84th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention and treatment, will be held June 21-24 in Orlando, Florida. More than 11,000 leading physicians, scientists and medical professionals from around the world are expected to convene both in-person and virtually to present cutting-edge diabetes research, treatment recommendations and cure advances. Attendees will have exclusive access to thousands of unique research presentations and will participate in inspiring and engaging interactions with leading diabetes experts. Join the Scientific Sessions conversation by using #ADAScientificSessions on social media.

About the American Diabetes Association The American Diabetes Association (ADA) is the nation's leading voluntary health organization working to stop the spread of diabetes and help people living with diabetes stay healthy. For 83 years, ADA has driven discovery and research into diabetes treatment, management and prevention, while tirelessly working to develop a cure. Through advocacy, program development and education, we strive to improve the quality of life for the more than 136 million Americans with diabetes or prediabetes. Diabetes connects us. What we do next connects us for life. To learn more or get involved, visit diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join us in the fight on Facebook (American Diabetes Association), Spanish Facebook (Asociacin Americana de la Diabetes), LinkedIn (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).

Media Contact: Amy Robinson [email protected]

Source: American Diabetes Association

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