Participants taking tilzepatide lost up to 52 pounds (24 kg) in this 72-week phase 3 study.
63% of participants taking tilzepatide 15 mg achieved at least 20% weight loss as a primary secondary endpoint
Indianapolis, April 28, 2022 / PRNewswire /-Tirzepatide (5 mg, 10 mg, 15 mg) is the top-line result of Eli Lilly and Company’s (NYSE: LLY) SURMOUNT-1 clinical trial, superior to placebo at 72 weeks of treatment. Achieved weight loss and participants estimated up to 22.5% of body weight (52 pounds or 24 kg) as an estimate of efficacy.Me.. The study enrolled 2,539 participants and was the first Phase 3 global enrollment study to evaluate the efficacy and safety of tilzepatide in overweight adults with obesity or at least one comorbidity without diabetes. was.Tirzepatide met both the key endpoints of a good average rate of change in body weight from baseline and a higher percentage of participants who achieved at least 5% weight loss compared to placebo for both estimates. rice fieldii.. The study also achieved all primary secondary endpoints in 72 weeks.
Efficacy estimates show that participants taking tyrzepatide averaged 16.0% (35 lbs or 16 kg at 5 mg), 21.4% (49 lbs or 22 kg at 10 mg), and 22.5% (52 lbs or 24 kg). Achieved weight loss. At 15 mg compared to placebo (2.4%, 5 lbs or 2 kg). In addition, 89% (5 mg) and 96% (10 mg and 15 mg) of people taking tilzepatide achieved at least 5% weight loss compared to 28% of people taking placebo. bottom.
In important secondary endpoints, 55% (10 mg) and 63% (15 mg) of people taking tyrzepatide were at least 20% compared to 1.3% of people taking placebo. Achieved weight loss. In an additional secondary endpoint unmanaged with Type 1 errors, 32% of participants taking tilzepatide 5 mg achieved at least 20% weight loss. The average baseline weight of the participants was 231 pounds (105 kg).
“Obesity is a chronic illness that often does not receive the same standard treatments as other conditions, despite its physical, psychological and metabolic health effects such as high blood pressure, heart disease, cancer and poor survival. “. Louis J. AlonneMD, FACP, DABOM, Director of General Weight Management Center Professor of Metabolism Research at Sanford I. Weillweil Cornell medicine, NewYork-Presbyterian / Weill Cornell Medical Center Obesity Expert and Investigator of SURMOUNT-1. “Tirzepatide has resulted in impressive weight loss in SURMOUNT-1. This may represent an important step forward for support. Patient-doctor partnership Treat this complex illness. “
For Treatment-Regimen EstimateiiiThe results showed that:
- Average weight loss: 15.0% (5 mg), 19.5% (10 mg), 20.9% (15 mg), 3.1% (placebo)
- Percentage of participants who achieved weight loss of 5% or more: 85% (5 mg), 89% (10 mg), 91% (15 mg), 35% (placebo)
- Percentage of participants who achieved weight loss of 20% or more: 30% (5 mg, uncontrolled with Type 1 error), 50% (10 mg), 57% (15 mg), 3.1% (placebo)
Overall safety And tolerability The profile of tyrzepatide was similar to other incretin-based therapies approved for the treatment of obesity. The most commonly reported adverse events were gastrointestinal-related, generally mild to moderately severe, and usually occurred during the dose escalation period. Tirzepatide (5 mg, 10 mg, 15 mg, respectively), nausea (24.6%, 33.3%, 31.0%), diarrhea (18.7%, 21.2%, 23.0%), vomiting (8.3%, 10.7%, 12.2%) and constipation (16.8%, 17.1%, 11.7%) were experienced more frequently than placebo (9.5%). [nausea]7.3% [diarrhea]1.7% [vomiting]5.8% [constipation]).
Treatment discontinuation rates due to adverse events were 4.3% (5 mg), 7.1% (10 mg), 6.2% (15 mg), and 2.6% (placebo). The overall discontinuation rates were 14.3% (5 mg), 16.4% (10 mg), 15.1% (15 mg), and 26.4% (placebo).
Participants who had prediabetes at the start of the study remained enrolled in SURMOUNT-1 for an additional 104 weeks of treatment from the first 72 weeks completion date, with weight effects and 3 o’clock 2 Assess the potential difference in progression to type 2 diabetes. Years of treatment with tyrzepatide compared to placebo.
“Tirzepatide is the first investigational drug to result in an average weight loss of 20% or more in Phase 3 trials, increasing confidence in its potential to help obese people,” he said. Jeff Emic, MD, Ph.D. , Vice President of Product Development, Lily. “Obesity is a chronic disease that requires effective treatment options, and Lily is constantly working to support obese people and modernize their approach to the disease. Potential like tilzepatide. We are proud to research and develop innovative treatments. Participants at the highest doses will lose at least 20% weight with SURMOUN T-1. “
Tirzepatide is a new weekly clinical trial GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1. (Glucagon-like peptide-1) Receptor agonists that represent a new class of drugs being studied for the treatment of obesity. Tirzepatide is a single peptide that activates the body’s receptors for the two natural incretin hormones, GIP and GLP-1. Obesity is a chronic, progressive disease caused by disruption of the mechanisms that control body weight, often leading to increased food intake and / or decreased energy expenditure. These confusions are multifactorial and can be related to genetic, developmental, behavioral, environmental and social factors. For more information, please visit Lilly.com/obesity.
Lily continues to evaluate the results of SURMOUN T-1. The results will be presented at the next medical conference and submitted to a peer-reviewed journal. Additional research is underway on tyrzepatide as a potential treatment for obesity or overweight.
About tyrzepatide
Tirzepatide is a weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist, a single novel molecule that acts on both incretins. Integrate into. GIP is a hormone that may complement the effects of GLP-1 receptor agonists. Preclinical models have shown that GIP loses weight because it reduces food intake and increases energy expenditure. When combined with GLP-1 receptor agonism, it can have a profound effect on markers of metabolic dysregulation such as body weight, glucose and lipids. .. Tirzepatide is in Phase 3 development for overweight adults with obesity or comorbidity associated with body weight and is currently under regulatory review as a treatment for adults with type 2 diabetes. It is also being studied as a potential treatment for heart failure with non-alcoholic steatohepatitis (NASH) and diastolic dysfunction (HFpEF). Studies of tyrzepatide in obstructive sleep apnea (OSA) and obesity morbidity / mortality are also planned.
About SURMOUNT-1 and SURMOUNT clinical trial programs
SURMOUNT-1 (NCT04184622) is a multicenter, randomized, double-blind, comparing the efficacy and safety of 5 mg, 10 mg, and 15 mg tylzepatides against placebo as a low-calorie diet supplement. A parallel, placebo-controlled study. Increased physical activity in adults without obesity, or overweight type 2 diabetes with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. The study randomized 2,539 participants across the United States. Argentina, Brazil, China, India, Japan, Mexico, Russia When Taiwan Administer either tyrzepatide 5 mg, 10 mg, 15 mg or placebo in a 1: 1: 1: 1 ratio. The main objective of this study was that tilzepatide 10 mg and / or 15 mg was superior in the rate of weight loss from baseline and the rate of participants who achieved a weight loss of 5% or more in 72 weeks compared to placebo. It was to prove that I was there. Participants who had prediabetes at the start of the study had an additional 104 weeks of treatment from the first 72 weeks completion date to assess the potential difference in body weight effects and progression to type 2 diabetes. Will remain registered with SURMOUN T-1. In 3 years of treatment Uses tilzepatide compared to placebo.
All participants in the tyrzepatide treatment group began the study with tyrzepatide 2.5 mg once weekly, followed by a gradual approach with a final randomized maintenance dose of 5 mg (2.5) at 4-week intervals. Increased to (via mg). Steps), 10 mg (via 2.5 mg, 5 mg, and 7.5 mg steps) or 15 mg (via 2.5 mg, 5 mg, 7.5 mg, 10 mg, and 12.5 mg steps).
Tirzepatide’s SURMOUNT Phase 3 Global Clinical Development Program began in late 2019, with more than 5,000 obese or overweight people enrolled in six clinical trials, four of which are global studies. Results for SURMOUNT-2, -3, and -4 are expected in 2023.
About Lily
Lily combines compassion and discovery to create medicines that improve the lives of people around the world. We have pioneered life-changing discoveries for nearly 150 years. And today, our medicines are helping more than 47 million people around the world. Our scientists are harnessing the power of biotechnology, chemistry and genetic medicine to urgently make new discoveries to solve some of the world’s most important health challenges and redefine diabetes treatment. And treats obesity, reduces its most devastating long-term effects, and is fighting Alzheimer’s disease, providing solutions to some of the diseases, the most debilitating immune system disorders, and the most difficult cancers to treat. Turns into a manageable illness. With each step towards a healthier world, we are motivated by one thing. It’s about making the lives of millions of people better. This includes providing innovative clinical trials that reflect the diversity of our world and ensuring that medicines are accessible and affordable. For more information, visit Lilly.com and Lilly.com/newsroom, Facebook, Instagram, twitter And LinkedIn. P-LLY
Lily’s note on forward-looking statements
This press release contains a statement about the future outlook for tyrzepatide as a potential treatment for obese or overweight adults (as defined by the Private Securities Litigation Reform Act of 1995) and future tyrzepatide-related issues. Includes a timeline for reads, presentations, and other milestones. And its her clinical trials, and Lily’s current beliefs and expectations. However, like any other drug, there are significant risks and uncertainties in the R & D and commercialization process. In particular, we cannot guarantee that the study will be completed as planned, that future study results will be consistent with previous results, or that tyrzepatide will be approved by the regulatory agency. For more information on these and other risks and uncertainties, please refer to Lily’s latest Form 10-K and Form 10-Q filings with the US Securities and Exchange Commission. Except as required by law, Lily undertakes no obligation to update any forward-looking statement to reflect events after this release date.
Dr. Aronne is a co-founder, Chief Scientific Advisor, and a member of the Board of Directors of Intellihealth. Dr. Aronne is also a member of Eli Lilly and Company’s paid scientific advisory board.
Me Estimated efficacy represents the efficacy of the investigational drug before discontinuation.
ii Treatment differences between the two estimates (efficacy and treatment regimen) were evaluated at three tyrzepatide doses (5 mg, 10 mg, and 15 mg) compared to placebo.
iii Treatment regimen estimates represent the estimated average therapeutic effect, regardless of treatment discontinuation.
Source Eli Lilly and Company
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