Lilly to present new research in the treatment of diabetes and obesity at the American Diabetes Association's® 83rd Scientific Sessions
Full SURMOUNT-2 phase 3 data on the efficacy and safety of tirzepatide for chronic weight management in adults with obesity or overweight and type 2 diabetes
New phase 2 data for retatrutide and orforglipron showcase promise of
"Our data presented at the
Key ADA Data Presentations
- SURMOUNT-2: The full results of the phase 3 clinical trial evaluating the efficacy and safety of tirzepatide for chronic weight management in adults with obesity or overweight and type 2 diabetes, will be presented in an
ADA-sponsored symposium. This presentation follows the topline data that Lillyannounced on April 27, which showed that tirzepatide led to superior weight reductions versus placebo for all doses. The symposium titled SURMOUNT-2 Trial Results and Potential Role of Tirzepatide in Treating Obesity in Type 2 Diabetes is scheduled on Friday, June 23, from 3:45-5:15 PM PDTand will be livestreamed for virtually registered attendees.
- Orforglipron: An oral presentation on
Lilly's phase 2 trial results will highlight the potential for orforglipron, a daily oral GLP-1, in adults with obesity or overweight with at least one weight-related comorbidity, compared to placebo. The oral presentation, Effect of Oral Nonpeptide GLP-1 Receptor Agonist Orforglipron (LY3502970) in Participants with Obesity or Overweight—A Phase 2 Study, is scheduled on Friday, June 23, from 2:15-2:30 PM PDTand will be livestreamed for virtually registered attendees. Lillywill also share phase 2 results of orforglipron in adults with type 2 diabetes in a poster presentation on Sunday, June 25from 11:30 AM-12:30 PM PDT.
- Retatrutide: The full results of two phase 2 studies evaluating retatrutide,
Lilly's GIP/GLP-1/Glucagon Receptor Triagonist, compared to placebo will be presented in an ADA-sponsored symposium. This presentation will discuss the efficacy and safety of retatrutide in adults with obesity or overweight with at least one weight-related comorbidity, as well as in people with type 2 diabetes. The symposium titled, Retatrutide (LY3437943), a Novel GIP/GLP-1/Glucagon Receptor Triagonist—Obesity, NAFLD, and T2D Phase 2 Trial Results, is scheduled on Monday, June 26, from 1:30-3:00 PM PDTand will be livestreamed for virtually registered attendees.
Key ADA Data Abstracts
Abstract Number and Title
SURMOUNT-2 Symposium: SURMOUNT-
750-P: SURPASS(ing) an Era of Basal-Bolus
52-OR: Effect of Oral Nonpeptide GLP-1
761-P: Effect of Orforglipron vs. Placebo and
Retatrutide Symposium: Retatrutide
The full list of abstracts at the
Orforglipron is an investigational nonpeptide oral glucagon-like peptide-1 (GLP-1) receptor agonist being studied for chronic weight management in people with obesity or overweight, as well as for glucose lowering in people with type 2 diabetes.
Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by
Retatrutide is an investigational single molecule that activates the body's receptors for three hormones – glucagon, glucose-dependent insulinotropic polypeptide (GIP), and glucagon-like peptide-1 (GLP-1), and is being studied for the treatment of obesity. Retatrutide is an acylated peptide suitable for weekly injection. Preclinical and phase 1 data have been published (Cell Metab 2022;
Tirzepatide is a once-weekly GIP receptor and GLP-1 receptor agonist. Tirzepatide is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones. Both GIP and GLP-1 receptors are found in areas of the human brain important for appetite regulation. Tirzepatide has been shown to decrease food intake and modulate fat utilization. Tirzepatide is in phase 3 development for adults with obesity, or overweight with weight-related comorbidity. It is also being studied as a potential treatment for people with obesity and/or overweight with heart failure with preserved ejection fraction (HFpEF), obstructive sleep apnea (OSA), and non-alcoholic steatohepatitis (NASH). Studies of tirzepatide in chronic kidney disease (CKD) and in morbidity/mortality in obesity (MMO) are also ongoing.
Tirzepatide was approved as Mounjaro® (tirzepatide) by the FDA on May 13, 2022. Mounjaro is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
MOUNJARO (tirzepatide) INDICATION AND SAFETY SUMMARY WITH WARNINGS
Mounjaro® (mown-JAHR-OH) is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).
- It is not known if Mounjaro can be used in people who have had inflammation of the pancreas (pancreatitis). Mounjaro is not for use in people with type 1 diabetes. It is not known if Mounjaro is safe and effective for use in children under 18 years of age.
Warnings - Mounjaro may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
- Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro.
Mounjaro may cause serious side effects, including:
Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.
Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro.
Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.
Common side effects
The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before using Mounjaro
- Your healthcare provider should show you how to use Mounjaro before you use it for the first time.
- Talk to your healthcare provider about low blood sugar and how to manage it.
- If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.
Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take other diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby or pass into your breast milk.
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
How to take
- Read the Instructions for Use that come with Mounjaro.
- Use Mounjaro exactly as your healthcare provider says.
- Mounjaro is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
- Use Mounjaro 1 time each week, at any time of the day.
- Do not mix insulin and Mounjaro together in the same injection.
- You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.
- Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
- If you take too much Mounjaro, call your healthcare provider or seek medical advice promptly.
Mounjaro is a prescription medicine. For more information, call 1-833-807-MJRO (833-807-6576) or go to www.mounjaro.com.
This summary provides basic information about Mounjaro but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you.
TR CON CBS 14SEP2022
Mounjaro® and its delivery device base are registered trademarks owned or licensed by
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about tirzepatide, orforglipron and retatrutide as potential treatments for adults with obesity or overweight and other diseases and the timeline for future readouts, presentations, and other milestones relating to tirzepatide, orforglipron and retatrutide and their clinical trials and reflects
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