SYNERGY-NASH outcomes have been introduced on the European Affiliation for the Examine of the Liver Congress 2024 and concurrently revealed in The New England Journal of Medication

INDIANAPOLIS, June 8, 2024 /PRNewswire/ — Eli Lilly and Firm (NYSE: NYSE:) introduced detailed outcomes from SYNERGY-NASH, a part 2 examine of 190 sufferers, with or with out sort 2 diabetes, to judge the investigational use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. The efficacy estimandⁱ confirmed 51.8%, 62.8% and 73.3% of members taking 5 mg, 10 mg and 15 mg, respectively, achieved an absence of MASH with no worsening of fibrosis on liver histology in comparison with 13.2% of members on placebo at 52 weeks of therapy, assembly the examine’s main endpoint. The information have been introduced on the European Affiliation for the Examine of the Liver (EASL) Congress 2024 and concurrently revealed in The New England Journal of Medication (NEJM).

In a secondary endpoint, the efficacy estimand confirmed 59.1%, 53.3% and 54.2% of members taking 5 mg, 10 mg and 15 mg, respectively, achieved a 1-stage or higher fibrosis enchancment with out worsening of MASH in comparison with 32.8% of members on placebo. Analysis of further secondary endpoints confirmed tirzepatide was related to enhancements in physique weight, blood markers of liver damage, and biomarkers of liver fats, irritation and fibrosis. Whereas the part 2 examine was not designed to show that tirzepatide improves fibrosis, the examine outcomes confirmed the potential for a clinically significant therapy impact throughout all doses.

“MASH is the second most common contributor to liver transplantation in the U.S., highlighting the need for novel therapies¹,” stated Rohit Loomba, MD, MHSc, chief of the division of gastroenterology and hepatology at College of California San Diego Faculty of Medication. “The study is significant, given the urgent need for treatment options that are capable of slowing the progression of the disease and potentially reducing serious health complications.”

Outcomes of the treatment-regimen estimandⁱⁱ analysis (beneath) have been in keeping with these noticed with the efficacy estimand:

p values for the secondary endpoint are nominal and never adjusted for a number of comparisons.

The general security profile of tirzepatide in SYNERGY-NASH was just like that noticed within the beforehand reported SURMOUNT and SURPASS trials. Essentially the most generally reported adversarial occasions in SYNERGY-NASH have been gastrointestinal-related (nausea, diarrhea, decreased urge for food, constipation and weight reduction) and customarily gentle to average in severity.

“Lilly is very pleased with the degree of MASH resolution observed in the SYNERGY-NASH study, and we are encouraged by the improvement of fibrosis observed,” stated Jeff Emmick, MD, PhD, senior vice chairman, product growth, Lilly. “MASH is expected to impact more than 19 million adults in the U.S. by 2039² and based on the study results, we believe tirzepatide may have the potential to help people living with this disease.”

Lilly is engaged with regulatory authorities on the following steps for tirzepatide for the therapy of MASH.

About SYNERGY-NASH

SYNERGY-NASH was a multicenter, double-blind, randomized, placebo-controlled part 2 examine evaluating the efficacy and security of tirzepatide at numerous doses in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH), beforehand known as nonalcoholic steatohepatitis (NASH), with stage 2 or 3 fibrosis. The trial randomized 190 members to obtain tirzepatide 5 mg, 10 mg, 15 mg or placebo, administered subcutaneously as soon as weekly for 52 weeks. The first endpoint was MASH decision with out worsening of fibrosis at 52 weeks. Secondary endpoints included fibrosis enchancment with out worsening of MASH.

About tirzepatide

Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist. Tirzepatide is a single molecule that prompts the physique’s receptors for GIP and GLP-1, that are pure incretin hormones. Each GIP and GLP-1 receptors are present in areas of the human mind essential for urge for food regulation. Tirzepatide has been proven to lower meals consumption and modulate fats utilization. Tirzepatide is being studied as a possible therapy for folks with weight problems and/or chubby with coronary heart failure with preserved ejection fraction (HFpEF), obstructive sleep apnea (OSA) and metabolic dysfunction-associated steatohepatitis (MASH). Research of tirzepatide in continual kidney illness (CKD) and in morbidity/mortality in weight problems (MMO) are additionally ongoing.

Tirzepatide was authorised by the FDA as Mounjaro ^® for adults with sort 2 diabetes to enhance glycemic management on Might 13, 2022, and as Zepbound ^® for adults with weight problems (a BMI of 30 kg/m² or higher) or those that are chubby (a BMI of 27 kg/m² or higher) who even have a weight-related comorbid situation on November 8, 2023. Each Mounjaro and Zepbound must be used as an adjunct to weight loss program and train.

INDICATION AND SAFETY SUMMARY WITH WARNINGS

Zepbound™ (ZEHP-bownd) is an injectable prescription medication that will assist adults with weight problems, or with extra weight (chubby) who even have weight-related medical issues, drop a few pounds and preserve it off. It must be used with a reduced-calorie weight loss program and elevated bodily exercise.

• • Zepbound accommodates tirzepatide and shouldn’t be used with different tirzepatide-containing merchandise or any GLP-1 receptor agonist medicines. It’s not identified if Zepbound is secure and efficient when taken with different prescription, over-the-counter, or natural weight reduction merchandise. It’s not identified if Zepbound can be utilized in individuals who have had pancreatitis. It’s not identified if Zepbound is secure and efficient to be used in youngsters underneath 18 years of age.

Warnings – Zepbound might trigger tumors within the thyroid, together with thyroid most cancers. Look ahead to potential signs, comparable to a lump or swelling within the neck, hoarseness, hassle swallowing, or shortness of breath. You probably have any of those signs, inform your healthcare supplier.

• Don’t use Zepbound in the event you or any of your loved ones have ever had a kind of thyroid most cancers referred to as medullary thyroid carcinoma (MTC).
• Don’t use Zepbound you probably have A number of Endocrine Neoplasia syndrome sort 2 (MEN 2).
• Don’t use Zepbound you probably have had a critical allergic response to tirzepatide or any of the components in Zepbound.

Zepbound might trigger critical negative effects, together with:

Extreme abdomen issues. Abdomen issues, generally extreme, have been reported in individuals who use Zepbound. Inform your healthcare supplier you probably have abdomen issues which are extreme or won’t go away.

Kidney issues (kidney failure). Diarrhea, nausea, and vomiting might trigger a lack of fluids (dehydration), which can trigger kidney issues. It is vital so that you can drink fluids to assist cut back your probability of dehydration.

Gallbladder issues. Gallbladder issues have occurred in some individuals who use Zepbound. Inform your healthcare supplier instantly in the event you get signs of gallbladder issues, which can embody ache in your higher abdomen (stomach), fever, yellowing of pores and skin or eyes (jaundice), or clay-colored stools.

Irritation of the pancreas (pancreatitis). Cease utilizing Zepbound and name your healthcare supplier instantly you probably have extreme ache in your abdomen space (stomach) that won’t go away, with or with out vomiting. You might really feel the ache out of your stomach to your again.

Critical allergic reactions. Cease utilizing Zepbound and get medical assist instantly you probably have any signs of a critical allergic response, together with swelling of your face, lips, tongue or throat, issues respiration or swallowing, extreme rash or itching, fainting or feeling dizzy, or very fast heartbeat.

Low blood sugar (hypoglycemia). Your danger for getting low blood sugar could also be greater in the event you use Zepbound with medicines that may trigger low blood sugar, comparable to a sulfonylurea or insulin. Indicators and signs of low blood sugar might embody dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred imaginative and prescient, slurred speech, shakiness, quick heartbeat, nervousness, irritability, temper modifications, starvation, weak spot or feeling jittery.

Adjustments in imaginative and prescient in sufferers with sort 2 diabetes. Inform your healthcare supplier you probably have modifications in imaginative and prescient throughout therapy with Zepbound.

Melancholy or ideas of suicide. It’s best to take note of modifications in your temper, behaviors, emotions or ideas. Name your healthcare supplier instantly you probably have any psychological modifications which are new, worse, or fear you.

Widespread negative effects

The most typical negative effects of Zepbound embody nausea, diarrhea, vomiting, constipation, abdomen (stomach) ache, indigestion, injection web site reactions, feeling drained, allergic reactions, belching, hair loss, and heartburn. These should not all of the potential negative effects of Zepbound. Speak to your healthcare supplier about any facet impact that bothers you or would not go away.

Inform your healthcare supplier you probably have any negative effects. You may report negative effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Earlier than utilizing Zepbound

• Your healthcare supplier ought to present you how to use Zepbound earlier than you employ it for the primary time.
• Inform your healthcare supplier if you’re taking medicines to deal with diabetes together with insulin or sulfonylureas which might improve your danger of low blood sugar. Speak to your healthcare supplier about low blood sugar ranges and how to handle them.
• If you happen to take contraception drugs by mouth, speak to your healthcare supplier earlier than you employ Zepbound. Contraception drugs might not work as effectively whereas utilizing Zepbound. Your healthcare supplier might advocate one other sort of contraception for 4 weeks after you begin Zepbound and for 4 weeks after every improve in your dose of Zepbound.

Overview these questions together with your healthcare supplier:

‘ Do you could have different medical situations, together with issues together with your pancreas or kidneys, or extreme issues together with your abdomen, comparable to slowed emptying of your abdomen (gastroparesis) or issues digesting meals?

‘ Do you’re taking diabetes medicines, comparable to insulin or sulfonylureas?

‘ Do you could have a historical past of diabetic retinopathy?

‘ Do you’re taking every other prescription medicines or over-the-counter medication, nutritional vitamins, or natural dietary supplements?

‘ Are you pregnant, plan to develop into pregnant, breastfeeding, or plan to breastfeed? Zepbound might hurt your unborn child. Inform your healthcare supplier in the event you develop into pregnant whereas utilizing Zepbound. It’s not identified if Zepbound passes into your breast milk. It’s best to speak together with your healthcare supplier about one of the best ways to feed your child whereas utilizing Zepbound.

• Being pregnant Publicity Registry: There shall be a being pregnant publicity registry for girls who’ve taken Zepbound throughout being pregnant. The aim of this registry is to gather details about the well being of you and your child. Speak to your healthcare supplier about how one can participate on this registry, or it’s possible you’ll contact Lilly at 1-800-LillyRx (1-800-545-5979).

Tips on how to take:

• Learn the Directions for Use that include Zepbound.
• Use Zepbound precisely as your healthcare supplier says.
• Zepbound is injected underneath the pores and skin (subcutaneously) of your abdomen (stomach), thigh, or higher arm.
• Use Zepbound 1 time every week, at any time of the day.
• Change (rotate) your injection web site with every weekly injection. Don’t use the identical web site for every injection.
• If you happen to take an excessive amount of Zepbound, name your healthcare supplier, search medical recommendation promptly, or contact a Poison Heart professional instantly at 1-800-222-1222.

Be taught extra:

Zepbound is a prescription medication. For extra data, name 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.

This abstract offers primary details about Zepbound however doesn’t embody all data identified about this medication. Learn the knowledge that comes together with your prescription every time your prescription is stuffed. This data doesn’t take the place of speaking together with your healthcare supplier. You’ll want to speak to your healthcare supplier about Zepbound and how to take it. Your healthcare supplier is the perfect individual that can assist you determine if Zepbound is best for you.

ZP CON CBS 08NOV2023

Zepbound™ and its supply machine base are emblems owned or licensed by Eli Lilly and Firm, its subsidiaries, or associates.

INDICATION AND SAFETY SUMMARY WITH WARNINGS

Mounjaro ® (mown-JAHR-OH) is an injectable medication for adults with sort 2 diabetes used together with weight loss program and train to enhance blood sugar (glucose).

• • It’s not identified if Mounjaro can be utilized in individuals who have had irritation of the pancreas (pancreatitis). Mounjaro isn’t to be used in folks with sort 1 diabetes. It’s not identified if Mounjaro is secure and efficient to be used in youngsters underneath 18 years of age.

Warnings – Mounjaro might trigger tumors within the thyroid, together with thyroid most cancers. Look ahead to potential signs, comparable to a lump or swelling within the neck, hoarseness, hassle swallowing, or shortness of breath. You probably have any of those signs, inform your healthcare supplier.

• Don’t use Mounjaro in the event you or any of your loved ones have ever had a kind of thyroid most cancers referred to as medullary thyroid carcinoma (MTC).
• Don’t use Mounjaro you probably have A number of Endocrine Neoplasia syndrome sort 2 (MEN 2).
• Don’t use Mounjaro if you’re allergic to it or any of the components in Mounjaro.

Mounjaro might trigger critical negative effects, together with:

Irritation of the pancreas (pancreatitis). Cease utilizing Mounjaro and name your healthcare supplier instantly you probably have extreme ache in your abdomen space (stomach) that won’t go away, with or with out vomiting. You might really feel the ache out of your stomach to your again.

Low blood sugar (hypoglycemia). Your danger for getting low blood sugar could also be greater in the event you use Mounjaro with one other medication that may trigger low blood sugar, comparable to a sulfonylurea or insulin. Indicators and signs of low blood sugar might embody dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred imaginative and prescient, slurred speech, shakiness, quick heartbeat, nervousness, irritability, or temper modifications, starvation, weak spot and feeling jittery.

Critical allergic reactions. Cease utilizing Mounjaro and get medical assist instantly you probably have any signs of a critical allergic response, together with swelling of your face, lips, tongue or throat, issues respiration or swallowing, extreme rash or itching, fainting or feeling dizzy, and really fast heartbeat.

Kidney issues (kidney failure). In individuals who have kidney issues, diarrhea, nausea, and vomiting might trigger a lack of fluids (dehydration), which can trigger kidney issues to worsen. It is vital so that you can drink fluids to assist cut back your probability of dehydration.

Extreme abdomen issues. Abdomen issues, generally extreme, have been reported in individuals who use Mounjaro. Inform your healthcare supplier you probably have abdomen issues which are extreme or won’t go away.

Adjustments in imaginative and prescient. Inform your healthcare supplier you probably have modifications in imaginative and prescient throughout therapy with Mounjaro.

Gallbladder issues. Gallbladder issues have occurred in some individuals who use Mounjaro. Inform your healthcare supplier instantly in the event you get signs of gallbladder issues, which can embody ache in your higher abdomen (stomach), fever, yellowing of pores and skin or eyes (jaundice), and clay-colored stools.

Widespread negative effects

The most typical negative effects of Mounjaro embody nausea, diarrhea, decreased urge for food, vomiting, constipation, indigestion, and abdomen (stomach) ache. These should not all of the potential negative effects of Mounjaro. Speak to your healthcare supplier about any facet impact that bothers you or would not go away.

Inform your healthcare supplier you probably have any negative effects. You may report negative effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Earlier than utilizing Mounjaro

• Your healthcare supplier ought to present you how to use Mounjaro earlier than you employ it for the primary time.
• Speak to your healthcare supplier about low blood sugar and how to handle it.
• If you happen to take contraception drugs by mouth, speak to your healthcare supplier earlier than you employ Mounjaro. Contraception drugs might not work as effectively whereas utilizing Mounjaro. Your healthcare supplier might advocate one other sort of contraception for 4 weeks after you begin Mounjaro and for 4 weeks after every improve in your dose of Mounjaro.

Overview these questions together with your healthcare supplier:

‘ Do you could have different medical situations, together with issues together with your pancreas or kidneys, or extreme issues together with your abdomen, comparable to slowed emptying of your abdomen (gastroparesis) or issues digesting meals?

‘ Do you’re taking different diabetes medicines, comparable to insulin or sulfonylureas?

‘ Do you could have a historical past of diabetic retinopathy?

‘ Are you pregnant, plan to develop into pregnant, breastfeeding, or plan to breastfeed? It’s not identified if Mounjaro will hurt your unborn child or move into your breast milk.

‘ Do you’re taking every other prescription medicines or over-the-counter medication, nutritional vitamins, or natural dietary supplements?

Tips on how to take

• Learn the Directions for Use that include Mounjaro.
• Use Mounjaro precisely as your healthcare supplier says.
• Mounjaro is injected underneath the pores and skin (subcutaneously) of your abdomen (stomach), thigh, or higher arm.
• Use Mounjaro 1 time every week, at any time of the day.
• Don’t combine insulin and Mounjaro collectively in the identical injection.
• You might give an injection of Mounjaro and insulin in the identical physique space (comparable to your abdomen space), however not proper subsequent to one another.
• Change (rotate) your injection web site with every weekly injection. Don’t use the identical web site for every injection.
• If you happen to take an excessive amount of Mounjaro, name your healthcare supplier or search medical recommendation promptly.

Be taught extra

Mounjaro is a prescription medication. For extra data, name 1-833-807-MJRO (833-807-6576) or go to www.mounjaro.com.

This abstract offers primary details about Mounjaro however doesn’t embody all data identified about this medication. Learn the knowledge that comes together with your prescription every time your prescription is stuffed. This data doesn’t take the place of speaking together with your healthcare supplier. You’ll want to speak to your healthcare supplier about Mounjaro and how to take it. Your healthcare supplier is the perfect individual that can assist you determine if Mounjaro is best for you.

TR CON CBS 14SEP2022

Mounjaro ^® and its supply machine base are registered emblems owned or licensed by Eli Lilly and Firm, its subsidiaries, or associates.

About Lilly
Lilly is a drugs firm turning science into therapeutic to make life higher for folks world wide. We have been pioneering life-changing discoveries for practically 150 years, and at the moment our medicines assist greater than 51 million folks throughout the globe. Harnessing the facility of biotechnology, chemistry and genetic medication, our scientists are urgently advancing new discoveries to resolve a few of the world’s most important well being challenges: redefining diabetes care; treating weight problems and curbing its most devastating long-term results; advancing the battle towards Alzheimer’s illness; offering options to a few of the most debilitating immune system problems; and remodeling probably the most difficult-to-treat cancers into manageable illnesses. With every step towards a more healthy world, we’re motivated by one factor: making life higher for tens of millions extra folks. That features delivering modern scientific trials that replicate the variety of our world and dealing to make sure our medicines are accessible and inexpensive. To study extra, go to Lilly.com and Lilly.com/information, or comply with us on Fb (NASDAQ:), Instagram and LinkedIn. P-LLY

ⁱ The efficacy estimand represents efficacy prior to check therapy discontinuation.
ⁱⁱ The treatment-regimen estimand represents the efficacy for randomized members no matter therapy discontinuation.
ⁱⁱⁱ The NAFLD Exercise Rating (NAS) is a histological rating that assesses the severity of illness exercise for metabolic dysfunction-associated steatotic liver illness (MASLD), previously referred to as non-alcoholic fatty liver illness (NAFLD).

References

1. Paklar N, Mijic M, Filipec-Kanizaj T. The Outcomes of Liver Transplantation in Extreme Metabolic Dysfunction-Related Steatotic Liver Illness Sufferers. Biomedicines. 2023;11(11):3096. doi:10.3390/biomedicines11113096
2. Younossi Z, Paik J, Henry L, Yang J, Fernades G, Stepanova M, Nader F. The Rising Financial and Scientific Burden of Nonalcoholic Steatohepatitis (NASH) in america. Journal of Scientific and Experimental Hepatology, 2022;13,3(454 “ 467). Doi:10.1016/j.jceh.2022.12.005

Cautionary Assertion Concerning Ahead-Trying Statements

This press release accommodates forward-looking statements (as that time period is outlined within the Non-public Securities Litigation Reform Act of 1995) about tirzepatide as a possible therapy for folks with metabolic dysfunction-associated steatohepatitis (MASH) and the timeline for future readouts, displays, and different milestones regarding tirzepatide and its scientific trials, and displays Lilly’s present beliefs and expectations. Nevertheless, as with all pharmaceutical product, there are substantial dangers and uncertainties within the means of drug research, growth, and commercialization. Amongst different issues, there is no such thing as a assure that deliberate or ongoing research shall be accomplished as deliberate, that future examine outcomes shall be in keeping with examine outcomes thus far, that tirzepatide will obtain regulatory approval and show to be a secure and efficient therapy for MASH, or that Lilly will execute its technique as anticipated. For additional dialogue of those and different dangers and uncertainties that might trigger precise outcomes to vary from Lilly’s expectations, see Lilly’s Kind 10-Ok and Kind 10-Q filings with the United States Securities and Trade Fee. Besides as required by legislation, Lilly undertakes no obligation to replace forward-looking statements to replicate occasions after the date of this launch.

Seek advice from: Brooke Frost; brooke.frost@lilly.com, 317-432-9145 (media)
Joe Fletcher; jfletcher@lilly.com, 317-296-2884 (traders)