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Jastreboff AM, et al. 3-CT-SY24. Introduced at: American Diabetes Affiliation Scientific Periods; June 3-7, 2022; New Orleans (hybrid assembly).
Disclosures:
Jastreboff experiences receiving guide or advisory charges from Boehringer Ingelheim, Eli Lilly, Intellihealth, Novo Nordisk, Pfizer and Scholar Rock and analysis assist from Eli Lilly and Novo Nordisk. Kaplan experiences receiving guide, speaker, advisory charges or analysis assist from Altimmune, Amgen, Allurion, Intellihealth, Janssen, Eli Lilly, Novo Nordisk, Pfizer, United Well being Group and Versanis, has an possession curiosity in ERX, Gelesis and Intellihealth, and serves on the board of administrators for ERX, Jamieson Wellness and Intellihealth. Please see the examine for all different authors’ related monetary disclosures.
NEW ORLEANS — Almost all contributors with weight problems with out diabetes assigned tirzepatide skilled at the very least 5% weight reduction over 72 weeks in contrast with placebo, with at the very least 20% weight reduction in additional than half with the very best 15 mg dose.
Within the SURMOUNT-1 examine, offered on the American Diabetes Affiliation Scientific Periods, researchers additionally famous a marked enchancment in a number of key cardiometabolic parameters for contributors assigned tirzepatide (Mounjaro, Eli Lilly), together with 95% of adults with prediabetes reverting to normoglycemia throughout the three doses analyzed. For the 15 mg dose of tirzepatide, greater than one-third of contributors skilled at the very least 25% physique weight discount in contrast with placebo, an exploratory endpoint of the examine.
“To place this into perspective, if somebody weighed 200 lb and misplaced better than or equal to 25% of their physique weight, they might have gone all the way down to 150 lb,” Ania Jastreboff, MD, PhD, affiliate professor of drugs and pediatrics (endocrinology) at Yale College Faculty of Medication, director of weight administration and weight problems prevention on the Yale Stress Heart, and co-director of the Yale Heart for Weight Administration, mentioned throughout a press convention. “We’re in a brand new period of weight problems remedy.”
Ania Jastreboff
As Healio beforehand reported, the FDA accepted tirzepatide, an investigational glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, in Might to enhance glucose response in adults with sort 2 diabetes along with eating regimen and train, primarily based on knowledge from the SURPASS scientific trial program. The drug will not be at present accepted to deal with weight problems.
Examine design
The SURMOUNT-1 examine included 2,539 adults with a BMI of at the very least 30 kg/m2 or at the very least 27 kg/m2 with at the very least one weight-related complication, excluding diabetes. Researchers randomly assigned contributors 5 mg, 10 mg or 15 mg tirzepatide or placebo as soon as weekly for 72 weeks, together with a 20-week dose-escalation interval. The co-primary endpoints had been proportion change in weight from baseline and weight discount of 5% or extra. Researchers used the treatment-regimen estimand to evaluate results no matter remedy discontinuation within the intention-to-treat inhabitants.
The outcomes had been concurrently revealed in The New England Journal of Medication.
At baseline, imply physique weight was 104.8 kg; imply BMI was 38 kg/m2.
At 72 weeks, imply proportion change in weight was –15% with the 5 mg tirzepatide dose (95% CI, –15.9 to –14.2), –19.5% with the ten mg dose (95% CI, –20.4 to –18.5), –20.9% with the 15 mg dose (95% CI, –21.8 to –19.9) and three.1% with placebo (95% CI, –4.3 to –1.9; P < .001 for all comparisons with placebo). The placebo-subtracted distinction for the 15 mg group was 17.8 proportion factors, Jastreboff mentioned throughout a presentation.
“There was a comparatively comparable weight discount for the ten mg and 15 mg teams, at the very least on common,” Jastreboff mentioned.
Throughout dosing teams, 85% (95% CI, 82-89), 89% (95% CI, 86-92) and 91% (95% CI, 88-94) of contributors misplaced at the very least 5% physique weight within the 5 mg, 10 mg and 15 mg tirzepatide teams, respectively, in contrast with 35% of contributors within the placebo group (95% CI, 30-39).
Within the 10 mg and 15 mg teams, 50% (95% CI, 46-54) and 57% (95% CI, 53-61) of contributors, respectively, skilled at the very least 20% discount in physique weight in contrast with 3% of these assigned placebo (95% CI, 1-5; P < .001 for all comparisons with placebo).
“Almost all contributors on the 15 mg dose, 97.7%, misplaced weight, whereas 2.3% gained weight,” Jastreboff mentioned. “This exhibits us that just about all misplaced weight with 10 mg and 15 mg and that there’s heterogeneity by way of response to tirzepatide, as we see with all therapies for weight problems.”
Cardiometabolic enhancements
Enhancements in all prespecified cardiometabolic measures had been noticed with tirzepatide, Jastreboff mentioned. Inside the cohort, 40% of contributors had prediabetes; the imply baseline HbA1c for contributors was 5.6%. Regardless of being within the normoglycemic vary, contributors within the tirzepatide teams skilled a imply 0.5% lower in HbA1c, Jastreboff mentioned. Greater than 95% of these with prediabetes reverted to normoglycemia within the tirzepatide teams.
Related enhancements had been noticed for lipids, blood stress and waist circumference.
Jastreboff famous triglyceride ranges decreased by greater than 27% within the pooled tirzepatide group vs. 6.3% for these assigned placebo.
The commonest antagonistic occasions with tirzepatide had been gastrointestinal and most had been delicate to reasonable in severity, occurring primarily throughout dose escalation.
Researchers famous the SURMOUNT-1 trial occurred within the midst of the COVID-19 pandemic, with recruitment starting in December 2019. Regardless of this, 86% of contributors general and 90% of contributors throughout the tirzepatide dosing teams accomplished the trial.
‘New technology’ of weight problems therapies
In dialogue after the presentation, Lee M. Kaplan, MD, PhD, FTOS, director of the Weight problems, Metabolism and Diet Institute at Massachusetts Basic Hospital, mentioned tirzepatide joins two different spectacular choices which might be a part of a “new technology” of efficient weight problems therapies: bariatric surgical procedure and the GLP-1 receptor agonist semaglutide (Wegovy, Novo Nordisk).
Lee M. Kaplan
“We’re in a brand new period of treating weight problems,” Kaplan mentioned. “That is likely one of the most essential conclusions from what we have now seen at present. There at the moment are three strikingly efficient and adequately protected therapies for weight problems. First is bariatric surgical procedure, second is semaglutide and now the third is tirzepatide.”
Kaplan careworn tirzepatide “will not be good.”
“Two-thirds of sufferers misplaced greater than 20% of their physique weight and 23% misplaced as a lot weight as seen with bariatric surgical procedure — 30%,” Kaplan mentioned. “Nevertheless, on the different excessive, about 3.7% misplaced lower than 5% of their physique weight. This variability turns into essential. We is not going to clear up everybody’s weight problems by treating all of them with tirzepatide, even when we might.”
Following the press convention, Jastreboff instructed Healio subanalyses are ongoing assessing the traits of contributors who didn’t reply properly to tirzepatide.
“We must also be aware that the response to the 5 mg dose is exceptional in and of itself,” Jastreboff instructed Healio. “[That data] was included as a key secondary endpoint as a result of, primarily based on the part 2 trial for individuals with sort 2 diabetes, researchers couldn’t predict their response to the drug. We have to know which doses and which medicines work finest for which sufferers. Proper now, the very best factor is for us to work carefully with our sufferers and see what they’re responding to. If they don’t seem to be responding to one thing, provide them a special remedy and guarantee we’re getting them to their weight and well being objectives with no matter remedy works for them.”
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