Novel Drugs Demonstrate Benefits of Once
Weekly Drugs for Weight Loss and Glycemic and Blood Pressure
Control
ORLANDO,
Fla., June 23, 2024 /PRNewswire/ -- Findings
from three studies showcase new data on the latest developments in
drug therapy innovations to treat obesity including new insights on
GLP-1 (Glucagon-like peptide-1) receptor agonists. The data was
presented as a late-breaking poster and oral presentations,
respectively at the American Diabetes Association® (ADA) 84th
Scientific Sessions in Orlando,
FL.
The studies are part of a host of research and development
driven by interest in new GLP-1 drugs and concerns about
obesity. Obesity affects about 125 million people in
the United States — 41.9% of
adults and 19.7% of children and adolescents. Notably, 90% of
people with diabetes also live with overweight or obesity. Weight
gain is a major problem for physicians and patients looking to
achieve adequate glycemic, blood pressure and lipid control in
patients with diabetes.
"Over the past few years, we have seen the substantial impact of
new research working to solve the dual health crisis we are facing,
obesity and diabetes," said Dr. Robert
Gabbay, chief scientific and medical officer for the ADA.
"The studies we are seeing presented at this year's annual meeting
show great promise to fuel new solutions and treatment options for
patients across the globe living with type 2 diabetes and
obesity."
Drug Treatment for Obesity Effectively Reduces Body
Weight and Blood Pressure
HRS9531 is a dual GLP-1/GIP (glucose-dependent insulinotropic
polypeptide) receptor agonist, offering a treatment option for
individuals with overweight or obesity, as well as type 2 diabetes.
This Phase 2 study evaluated the efficacy and safety of HRS9531 in
obese adults without diabetes. The research found HRS9531
effectively reduced body weight, blood pressure, blood glucose, and
triglycerides, with a favorable safety profile.
The double-blind, randomized, placebo-controlled Phase 2 trial
studied a total of 249 Chinese adults with a body mass index of
28-40 kg/m². Participants were randomized into five groups to
receive once-weekly subcutaneous injections of HRS9531 (1.0 mg, 3.0
mg, 4.5 mg, and 6.0 mg) or placebo for 24 weeks. The primary
endpoint was the percentage change in body weight at week 24.
Greater weight loss was achieved in individuals receiving
HRS9531 compared with those receiving placebo. At the end of the
24-week intervention, participants in 1.0 mg, 3.0 mg, 4.5 mg, and
6.0 mg HRS9531 groups achieved weight reductions of 5.4%, 13.4%,
14.0%, and 16.8% respectively, as compared with 0.1% reduction in
the placebo group. Moreover, the proportion of participants
achieving ≥5% weight reduction was 52.0%, 88.2%, 92.0%, 91.8%, and
10.2%, respectively. Most adverse events (AEs) were mild or
moderate, and the most common AEs were nausea, diarrhea, decreased
appetite, and vomiting, occurring primarily during dose escalation.
The overall safety and tolerability profile of HRS9531 is
consistent with other GLP-1 agonists.
"People living with obesity are at a high risk of developing
chronic diseases such as type 2 diabetes and cardiovascular
disease. Losing weight significantly reduces the risk of those
diseases," said Xiaoying Li, MD,
PhD. Professor and Director, Department of Endocrinology and
Metabolism, Zhongshan Hospital Fudan University, China, and senior author. "Since dietary and
exercise intervention alone is often not enough, we were pleased to
see that this could be a potentially promising treatment for weight
management, potentially enhancing their overall health and
significantly reducing the societal burden of obesity."
The authors of the study note a Phase 3 study with HRS9531 in
Chinese overweight or obese individuals is already ongoing and
multi-regional studies are being planned.
Experimental Medication, Pemvidutide, Reveals 15.6%
Average Total Body Weight Loss for Patients with Overweight and
Obesity
The Phase 2 MOMENTUM trial evaluated the potential for
pemvidutide, Altimmune's investigational medication, a
GLP-1/Glucagon dual receptor agonist, in development for obesity
and a liver disease called metabolic-dysfunction associated
steatohepatitis (MASH), to help people with overweight and obesity
lose weight. The trial revealed promising results - significantly
reducing body weight and serum lipids over 48 weeks of
treatment. In addition, body composition analysis
demonstrated class-leading preservation of lean mass.
This Phase 2, randomized, placebo-controlled trial enrolled 391
subjects with overweight or obesity, but without diabetes, and
administered either pemvidutide at three dose levels (1.2, 1.8, 2.4
mg) or a placebo weekly for 48 weeks. Neither the investigators nor
the subjects knew what treatment they were receiving.
After 48 weeks, subjects at the highest pemvidutide dose had
lost an average of 15.6% of their total body weight, and the
treatment appeared to be safe and well-tolerated. Several potential
advantages of this approach to weight loss were identified,
including a simple dosing regimen and significant decreases in the
amount of lipids (such as cholesterol and triglycerides) present in
the blood and the liver, which may help reduce the risk of
cardiovascular disease. Additionally, results from a body
composition sub-study were presented indicating class-leading
preservation of lean mass, with only 21.9% attributable to lean
mass and 78.1% of weight loss due to fat. Preserving lean mass,
which primarily includes muscle, is believed to be critical for
maintaining physical function and decreasing the risk of bone
fractures.
"Obesity and its associated comorbidities represent a major and
growing health challenge. A variety of therapeutic approaches will
be required to meet the specific needs of each patient to
effectively manage their weight and address other obesity-related
conditions they may have," said Louis J.
Aronne, MD, FACP, DABOM, Weill Cornell Medicine,
New York City, NY, and primary
investigator. "These findings demonstrated that the use of
pemvidutide may have important effects on the quality of weight
loss and cardiometabolic-associated comorbidities of obesity.
Furthermore, as the focus shifts to long-term weight management,
the preservation of lean mass will be critical for patient
care."
The authors of this study are preparing for larger Phase 3
registrational trials intended to demonstrate the safety and
clinical benefit of pemvidutide for weight management. In addition,
because obesity can lead to the accumulation of excess liver fat
and MASH, they are also studying pemvidutide in patients with this
condition.
Retatrutide Improves Ability of Insulin to Lower Blood
Sugar for People Living with Type 2 Diabetes
Biomarker analyses may help in the understanding of diseases and
identifying specific therapeutic targets. A new study evaluated
biomarkers to observe how treatment with retatrutide affects
pancreatic beta cells that make insulin as well as biomarkers
associated with the body's ability to respond to insulin to lower
blood sugar. In this study, exploratory biomarker research within
phase 2 clinical trials was examined to further understand on the
molecular level how retatrutide may work and further help explain
primary results.
The research found treatment with retatrutide increased markers
of well-functioning insulin-producing beta cells (HOMA2-B) and the
ability of insulin to lower blood sugar (adiponectin). The results
also demonstrated how retatrutide decreased markers of stress on
insulin-producing cells, as assessed by measuring immature insulin
(proinsulin) and reduction in a marker of insulin resistance
(HOMA2-IR).
"This study matters because many people living with type 2
diabetes are taking multiple diabetes medications to try to reach
blood sugar targets, and new medications that have the potential to
help simplify treatment regimens are needed," said Melissa K. Thomas, MD, PhD, Vice President,
Diabetes and Metabolic Research, Lilly Research Laboratories,
Indianapolis, IN, and one of the
investigators conducting the study. "We are encouraged to see that
people living with either obesity or with type 2 diabetes in our
clinical studies had lowered blood sugar and had improved responses
to insulin."
Several Phase 3 clinical trials are underway studying
retatrutide in people living with type 2 diabetes or obesity
without type 2 diabetes including the TRIUMPH and TRANSCEND Phase 3
trials.
Research presentation details:
Dr. Zeng will present the findings at the following
late-breaking poster session:
- Late-Breaking Posters:
Efficacy and Safety of HRS9531, a Novel Dual GLP-1/GIP Receptor
Agonist, in Obese Adults—A Phase 2 Trial
- Presented on Saturday, June 22,
2024 at 12:30 PM EDT
Dr. Aronne will present the findings at the following
presentation session:
- Oral Presentations - Weighing Opportunities of
Incretin-Based Therapy in Obesity Pemvidutide, a
GLP-1/Glucagon Dual Receptor Agonist, in Subjects with Overweight
or Obesity—A 48-Week, Placebo-Controlled, Phase 2 (MOMENTUM)
Trial
- Presented on Sunday, June 23,
2024 at 1:45 PM EDT
Dr. Thomas will present the findings at the following oral
presentation session:
- Oral Presentations - Weighing Opportunities of Incretin-Based
Therapy in Obesity Retatrutide, an Agonist of GIP, GLP-1, and
Glucagon Receptors, Improves Markers of Pancreatic Beta-Cell
Function and Insulin Sensitivity
- Presented on Sunday, June 23,
2024 at 2:45 PM EDT
About the ADA's Scientific Sessions
The ADA's 84th
Scientific Sessions, the world's largest scientific meeting focused
on diabetes research, prevention, and care, will be held in
Orlando, FL on June 21-24. More than 11,000 leading physicians,
scientists, and health care professionals from around the world are
expected to convene both in person and virtually to unveil
cutting-edge research, treatment recommendations, and advances
toward a cure for diabetes. Attendees will receive exclusive access
to thousands of original research presentations and take part in
provocative and engaging exchanges with leading diabetes experts.
Join the Scientific Sessions conversation on social media using
#ADAScientificSessions.
About the American Diabetes Association
The American
Diabetes Association (ADA) is the nation's leading voluntary health
organization fighting to bend the curve on the diabetes epidemic
and help people living with diabetes thrive. For 83 years, the ADA
has driven discovery and research to treat, manage, and prevent
diabetes while working relentlessly for a cure. Through advocacy,
program development, and education we aim to improve the quality of
life for the over 136 million Americans living with diabetes or
prediabetes. Diabetes has brought us together. What we do next will
make us Connected for Life®. To learn more or to get involved,
visit us at diabetes.org or call 1-800-DIABETES
(1-800-342-2383). Join the fight with us on Facebook (American
Diabetes Association), Spanish Facebook (Asociación Americana de la
Diabetes), LinkedIn (American Diabetes Association), Twitter
(@AmDiabetesAssn), and Instagram (@AmDiabetesAssn).
Media Contact:
Amy Robinson
arobinson@brgcommunications.com
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SOURCE American Diabetes Association