Tirzepatide Decreased The Chance Of Developing Type 2 Diabetes By 94% In Persons With Pre-Diabetes, Obesity, Or Overweight.
Indianapolis, August 20, 2024 (PRNewswire) — Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the SURMOUNT-1 three-year study (176-week treatment period) evaluating the efficacy and safety of tirzepatide (Zepbound® and Mounjaro®) once weekly for long-term weight management and delayed progression to diabetes in adults with pre-diabetes, obesity, or overweight. Weekly tirzepatide injections (5 mgi, 10 mg, 15 mg) reduced the incidence of progression to type 2 diabetes by 94% ii among persons with pre-diabetes, obesity, or overweight when compared to placebo. Furthermore, treatment with tirzepatide resulted in sustained weight loss across the treatment duration. At the end of the treatment period, adults on the 15 mg dose had a 22.9% overall average drop in body weight, compared to 2.1% for placebo in adults with pre-diabetes, obesity, or overweight.
“Obesity is a chronic disease that increases the risk of other complications such as type 2 diabetes in nearly 900 million adults worldwide,” said Jeff Emmick, M.D., Ph.D., senior vice president, product development at Lilly. “Tirzepatide lowered the chance of acquiring type 2 diabetes by 94% and resulted in consistent weight loss over a three-year treatment period. These findings support the potential clinical benefits of long-term treatment for persons with obesity and pre-diabetes.”
Tirzepatide was tested in 1,032 persons with pre-diabetes at randomization and obesity or overweight for 176 weeks, followed by a 17-week off-treatment interval (193 weeks total). In 2022, the New England Journal of Medicine published the results of the SURMOUNT-1 phase 3 study’s principal analysis at 72 weeks in all participants.
Tirzepatide significantly reduced the chance of developing type 2 diabetes in persons with pre-diabetes, obesity, or overweight from baseline to week 176 (p<0.0001, adjusted for type 1 error). Pooled doses of tirzepatide demonstrated significant efficacy estimates, with a 94% reduction in risk of progression to type 2 diabetes compared to placebo up to week 176. Up to week 176, pooled dosages of tirzepatide reduced the probability of developing type 2 diabetes by 93% compared to placebo.
Tirzepatide (10 mg and 15 mg) significantly reduced weight in persons with pre-diabetes, obesity, or overweight compared to placebo from baseline to week 176 (p<0.001, corrected for type 1 error). At week 176, adults receiving tirzepatide lost an average of 15.4% (5 mg), 19.9% (10 mg), and 22.9% (15 mg) more weight than those on placebo (2.1%). At week 176, persons using tirzepatide lost an average of 12.3% (5 mg), 18.7% (10 mg), and 19.7% (15 mg) more weight than those taking placebo (1.3%).
During the 17-week off-treatment period, those who had discontinued tirzepatide began to gain weight and had an increase in the progression to type 2 diabetes, resulting in an 88% reduction (p<0.0001, controlled for type 1 error) in the risk of progression to type 2 diabetes compared to placebo.
The overall safety and tolerability profile of tirzepatide across the 193-week study was consistent with previously published primary outcomes at 72 weeks in SURMOUNT-1 and other tirzepatide clinical trials for chronic weight management. The most often reported adverse effects were typically gastrointestinal in nature and of mild to moderate intensity. The most common gastrointestinal side effects for tirzepatide patients were diarrhea, nausea, constipation, and vomiting.
Tirzepatide, a GIP and GLP-1 receptor agonist, functions by activating both hormone receptors. GLP-1 regulates appetite and calorie intake. Nonclinical studies indicate that the inclusion of GIP may aid in the regulation of food consumption. Tirzepatide reduces calorie intake, and the effects are most likely mediated by changes in appetite. Furthermore, tirzepatide promotes insulin secretion in a glucose-dependent way. Tirzepatide improves insulin sensitivity in people with type 2 diabetes, which can lead to a drop in blood glucose levels.
These topline data show that tirzepatide reduces the chance of developing type 2 diabetes and maintains weight loss in persons with pre-diabetes, obesity, or overweight. Detailed findings will be submitted to a peer-reviewed journal and presented at ObesityWeek 2024, which will be held November 3–6.
About SURMOUNT-1
SURMOUNT-1 (NCT04184622) was a multi-center, randomized, double-blind, parallel, placebo-controlled trial that compared the efficacy and safety of tirzepatide 5 mg, 10 mg, and 15 mg to placebo as an adjunct to a reduced-calorie diet and increased physical activity in adults without type 2 diabetes who are obese or overweight and have at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea (OSA), or cardiovascular disease. The 1,032 participants who had pre-diabetes at the start of the study remained enrolled in SURMOUNT-1 for an additional 104 weeks of treatment after the initial 72-week completion date to assess the impact on body weight and potential differences in progression to type 2 diabetes after three years of treatment with tirzepatide versus placebo.
Tirzepatide is a once-weekly agonist of GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptors, which are natural incretin hormones found in areas of the human brain important for appetite regulation. It has been shown to reduce food intake and modulate fat utilization.
Lilly plans to submit data for tirzepatide in heart failure with preserved ejection fraction (HFpEF) and obesity to the U.S. FDA and other global regulatory agencies later this year. Tirzepatide was approved by the U.S. FDA as Mounjaro® for adults with type 2 diabetes to improve glycemic control on May 13, 2022, and as Zepbound® for adults with obesity (a BMI of 30 kg/m2 or greater) or overweight (a BMI of 27 kg/m2 or greater) who also have a weight-rela
Tirzepatide is the only approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) therapy for persistent obesity. Mounjaro® and Zepbound® should be used in combination with a healthy diet and regular exercise.
INDICATION AND SAFETY SUMMARY, WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription drug that may help adults who are obese or have excess weight (overweight) and have weight-related medical problems reduce and maintain their weight. It should be combined with a lower-calorie diet and more physical activity.
Zepbound contains tirzepatide, which should not be combined with other tirzepatide-containing drugs or GLP-1 receptor-agonist medications. It is unclear whether Zepbound is safe and effective when combined with other prescription, over-the-counter, or herbal weight-loss medications. It is unclear whether Zepbound can be used in patients who have experienced pancreatitis. It is unclear whether Zepbound is safe and effective for use by children under the age of 18.
Warnings: Zepbound may cause thyroid tumors, including cancer. Look for signs of a lump or enlargement in the neck, hoarseness, difficulty swallowing, or shortness of breath. If you have any of these symptoms, contact your doctor.
Do not use Zepbound if you or anybody in your family has ever had medullary thyroid carcinoma (MTC).
Zepbound should not be used if you have Multiple Endocrine Neoplasia Syndrome type 2 (MEN 2).
Do not use Zepbound if you have experienced a severe allergic response to tirzepatide or any of its constituents.
Zepbound may have major side effects, such as:
Severe stomach issues: People who take Zepbound have reported stomach problems, some of which are severe. Tell your doctor if you experience serious stomach troubles that won’t go away.
Kidney troubles (failure): Diarrhea, nausea, and vomiting may induce fluid loss (dehydration), which can lead to renal problems. You should drink enough fluids to lower your chances of becoming dehydrated.
Gallbladder issues: Some Zepbound users have reported gallbladder troubles. If you have gallbladder symptoms such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored feces, see your doctor right away.
Pancreatic inflammation: Stop using Zepbound and contact your doctor right away if you have severe stomach discomfort (abdomen) that does not go away, with or without vomiting. You may experience pain across your abdomen and back.
Severe allergic responses: Stop using Zepbound and seek medical attention right away if you experience any of the following symptoms of a significant allergic reaction: swelling of your face, lips, tongue, or throat; difficulty breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or a very rapid heartbeat.
Hypoglycemia (low blood sugar): If you combine Zepbound with other blood sugar-lowering medications, such as sulfonylureas or insulin, your chance of developing low blood sugar may increase. Low blood sugar symptoms may include dizziness or lightheadedness, perspiration, confusion or sleepiness, headache, blurred vision, slurred speech, shakiness, rapid heartbeat, anxiety, irritability, mood changes, hunger, weakness, or jitteriness.
Vision changes in people with type 2 diabetes: If your vision changes while using Zepbound, notify your healthcare professional.
Depression or suicidal ideation: Pay attention to changes in your mood, behavior, sensations, or thoughts. If you see any new, worsening, or concerning mental changes, contact your healthcare practitioner immediately.
Common side effects
Zepbound’s most common side effects are nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site responses, fatigue, allergic reactions, belching, hair loss, and heartburn. These are not the only probable negative effects of Zepbound. Inform your healthcare practitioner if you are experiencing any side effects that are bothering you or are persistent.
Inform your healthcare practitioner if you experience any side effects. To report side effects, call 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Before using Zepbound
Before you begin using Zepbound for the first time, your healthcare provider should demonstrate how to do so.
Tell your doctor if you are using any diabetes medications, such as insulin or sulfonylureas, which may raise your risk of low blood sugar. Consult your healthcare professional about low blood sugar levels and how to manage them.
If you take birth control tablets orally, see your doctor before using Zepbound. Birth control pills may not be as effective while taking Zepbound. Your healthcare practitioner may advise you to use a different method of birth control for the first four weeks after starting Zepbound and for each subsequent four-week dose increase.
Discuss these questions with your healthcare provider:
Do you have any other medical illnesses, such as pancreas or renal difficulties, or significant stomach problems, such as delayed emptying (gastroparesis) or difficulty digesting food?
❑ Do you use diabetes medications, like insulin or sulfonylureas?
❑ Have you ever had diabetic retinopathy?
Do you take any additional prescription or OTC medications, vitamins, or herbal supplements?
❑ Are you pregnant, planning to get pregnant, breastfeeding, or intending to breastfeed?
Zepbound may harm your unborn child. Inform your healthcare provider if you become pregnant while taking Zepbound. It is unknown whether Zepbound goes into your breast milk. You should consult your healthcare professional about the best manner to feed your infant while on Zepbound.
Pregnancy Exposure Registry: A pregnancy exposure registry will be established for women who took Zepbound during their pregnancy. This registry’s objective is to collect health-related information about you and your baby. Talk with your healthcare practitioner about how you might participate in this registry, or you may contact Lilly at 1-800-LillyRx (800-545-5979).
How To Take
Read the Zepbound instructions.
Follow the instructions provided by your healthcare professional when using Zepbound.
Zepbound is injected subcutaneously into your stomach, thigh, or upper arm.
Use Zepbound once each week, at any time of day.
Change (rotate) your injection site every week. Do not inject at the same place each time.
If you take too much Zepbound, call your doctor immediately, get medical help, or contact a Poison Center expert at 1-800-222-1222.
Learn more
Zepbound is a prescription medication. For additional information, call 1-800-LillyRx (1-800–545-5979) or visit.
This overview gives basic information about Zepbound but may not include all of the information available about this medication. Read the information that comes with your medication every time it is filled. This material is not intended to replace a conversation with your healthcare physician. Consult your healthcare professional about Zepbound and how to take it. Your healthcare practitioner is the best person to help you determine whether Zepbound is suitable for you.
ZP CON CBS 08NOV2023
Eli Lilly and Company, its subsidiaries, and affiliates own or license the registered trademarks Zepbound® and its delivery device foundation.
INDICATION AND SAFETY SUMMARY, WITH WARNINGS
Mounjaro® (pronounced mown-JAHR-OH) is an injectable drug for adults with type 2 diabetes that is used in conjunction with diet and exercise to improve blood sugar levels.
It is unclear whether Mounjaro can be utilized in persons who have suffered pancreatic inflammation. Mounjaro is not recommended for patients with type 1 diabetes. It is unclear whether Mounjaro is safe and effective for usage in children under the age of 18.
Warnings: Mounjaro may cause thyroid tumors, including thyroid cancer. Look for signs of a lump or enlargement in the neck, hoarseness, difficulty swallowing, or shortness of breath. If you have any of these symptoms, contact your doctor.
Do not take Mounjaro if you or anybody in your family has had medullary thyroid carcinoma (MTC).
Mounjaro should not be used if you have Multiple Endocrine Neoplasia Syndrome type 2 (MEN 2).
Do not use Mounjaro if you have an allergy to it or any of its ingredients.
Mounjaro may have major negative effects, such as:
Pancreatic inflammation: Stop using Mounjaro and contact your doctor straight away if you have severe stomach discomfort (abdomen) that does not go away, with or without vomiting. You may experience pain across your abdomen and back.
Hypoglycemia (low blood sugar): If you use Mounjaro with another blood sugar-lowering medication, such as a sulfonylurea or insulin, your chances of developing low blood sugar may increase. Low blood sugar symptoms may include dizziness or lightheadedness, perspiration, confusion or sleepiness, headache, blurred vision, slurred speech, shakiness, rapid heartbeat, anxiety, irritability, or mood swings, hunger, weakness, and jitteriness.
Severe allergic responses: Stop taking Mounjaro and get medical attention right away if you experience any of the following symptoms of a significant allergic reaction: swelling of your face, lips, tongue, or throat, difficulty breathing or swallowing, severe rash or itching, fainting or feeling disoriented, and a very rapid heartbeat.
Kidney troubles (failure):Diarrhea, nausea, and vomiting can induce fluid loss (dehydration) in persons with kidney difficulties, exacerbating the condition. You should drink enough of fluids to lower your chances of becoming dehydrated.
Severe stomach issues: People who use Mounjaro have reported stomach problems, some of which are serious. Tell your doctor if you experience serious stomach troubles that won’t go away.
Changes in vision: If your vision changes while taking Mounjaro, notify your healthcare provider.
Gallbladder issues: Some Mounjaro users have reported gallbladder troubles. If you experience symptoms of gallbladder difficulties, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored feces, see your doctor immediately.
Common side effects
The most common Mounjaro side effects are nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach discomfort. These aren’t the only probable Mounjaro side effects. Inform your healthcare practitioner if you are experiencing any side effects that are bothering you or are persistent.
Inform your healthcare practitioner if you experience any side effects. To report side effects, call 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Before using Mounjaro
Before you begin using Mounjaro for the first time, your healthcare provider should demonstrate how to use it.
Consult your healthcare professional about low blood sugar and how to treat it.
If you take birth control tablets orally, see your doctor before using Mounjaro. Birth control pills may not be as effective while taking Mounjaro. Your healthcare practitioner may advise you to use another method of birth control for the first four weeks after starting Mounjaro and for each subsequent four-week increase in dose.
Discuss these questions with your healthcare provider:
❑ Do you have other medical conditions, such as problems with your pancreas or kidneys, or serious stomach problems, such as sluggish emptying (gastroparesis) or difficulty digesting food?
❑ Do you take any other diabetes medications, like insulin or sulfonylurea?
❑ Have you ever had diabetic retinopathy?
❑ Are you pregnant, planning to get pregnant, breastfeeding, or intending to breastfeed? It is unclear whether Mounjaro will harm your unborn child or pass into your breast milk.
❑ Do you take any additional prescription or over-the-counter medications, vitamins, or herbal supplements?
How To Take
Read Mounjaro’s instructions for use.
Follow the instructions provided by your healthcare professional when using Mounjaro.
Mounjaro is injected subcutaneously into your stomach, thigh, or upper arm.
Use Mounjaro once every week, at any time of day.
Do not combine insulin with Mounjaro in the same injection.
You can inject Mounjaro and insulin in the same body location (such as your stomach), but not exactly next to each other.
Change (rotate) your injection site every week. Do not inject at the same place each time.
If you take too much Mounjaro, contact your healthcare practitioner or seek medical assistance immediately.
Learn more
Mounjaro is a prescription medication. For additional information, call 1-833-807-MJRO (833-807-6576) [or visit www.mounjaro.com].
This overview includes basic information about Mounjaro but does not cover all of the available information regarding this drug. Read the information that comes with your medication every time it is filled. This material is not intended to replace a conversation with your healthcare physician. Consult your healthcare practitioner about Mounjaro and how to take it. Your healthcare practitioner is the best person to advise you on whether Mounjaro is a good fit for you.
TR CON CBS, 14SEP2022
Eli Lilly and Company, its subsidiaries, and affiliates own or license the registered trademarks Mounjaro® and its delivery device foundation.
About Lilly
Lilly is a medical company that transforms knowledge into therapy to improve people’s lives all over the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and our medications now benefit over 51 million people worldwide. Our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and reducing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into With each stride toward a healthier world, we are inspired by one goal: to improve the lives of millions of people. This means conducting creative clinical studies that reflect our world’s diversity, as well as aiming to make our medications more accessible and cheap. For additional information, please visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY
I did not control for type 1 errors
ii The efficacy estimand represents efficacy if all patients stayed on randomized treatment for the entire scheduled term (up to 176 weeks).
iii The treatment-regimen estimand represents efficacy regardless of adherence to the randomized treatment.
Cautionary Statement About Forward-Looking Statements
This press release contains forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995), including statements about tirzepatide injection for the treatment of adults with type 2 diabetes, tirzepatide as a potential long-term therapy for adults with pre-diabetes, obesity or overweight, and the timeline for future presentations and other milestones relating to tirzepatide and its clinical trials, and reflects Lilly’s current However, like with any pharmaceutical product, there are significant dangers and uncertainties in the process of research development. commercialization. Among other things, there is no guarantee that planned or existing trials will be completed as planned, that future research results will be consistent with those obtained thus far, that tirzepatide will acquire additional regulatory clearances, or that tirzepatide will be commercially successful. For a more in-depth discussion of these and other risks and uncertainties, please see Lilly’s most recent Form 10-K and Form 10-Q filings with the US Securities and Exchange Commission. Except as required by law, Lilly has no obligation to update forward-looking statements to reflect events occurring after the date of this release.
