Sticking with weekly semaglutide injections resulted in continued weight reduction for adults with chubby and weight problems, in accordance with the Semaglutide Remedy Impact in Individuals with Weight problems (STEP) 4 examine.
On this 68-week, randomized double-blind trial amongst adults with weight problems however freed from diabetes, imply weight reduction for these on 2.4 mg semaglutide totalled 17.8 kg (39.2 lb), with 7.1 kg (15.6 lb) of that loss coming after members had already been on the drug for 20 weeks, reported Domenica Rubino, MD, of the Washington Middle for Weight Administration and Analysis in Arlington, Virginia, and colleagues.
The trial included 803 members who all accomplished a 20-week run-in section, by which they acquired the glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide — beginning with 16 preliminary weeks of dose escalation till they reached 4 weeks on the total upkeep dose of two.4 mg per week — along with life-style intervention aimed round a 500-calorie-deficit weight loss program and goal of 150 minutes per week of bodily exercise.
All members had been 18 or older with at the least one prior unsuccessful try and shed weight via weight loss program. Members had a physique mass index (BMI) of 30 or larger, or a BMI of ≥27 plus at the least one weight-related comorbidity together with hypertension, dyslipidemia, obstructive sleep apnea, or heart problems. Not one of the members had sort 2 diabetes at baseline.
Throughout these preliminary 20 weeks, the whole cohort skilled a mean lack of 10.6% of baseline physique weight.
Following this, 535 members — who already achieved their goal upkeep dose of two.4 mg weekly — had been randomized to proceed on their 2.4-mg-per-week dose of semaglutide for a further 48 weeks. They had been in contrast with 268 members who had been switched to placebo.
All through the remaining 48 weeks of the trial, those that continued on semaglutide continued to shed the kilos, dropping a further common of seven.9% of physique weight. Then again, those that had been switched to placebo noticed the burden loss advantages reverse, gaining again a mean of 6.9% of physique weight (distinction -14.8%, 95% CI -16.0 to -13.5%, P<0.001).
Those that continued on remedy additionally noticed a slew of different advantages, together with a major drop in waist circumference (-9.7 cm, 95% CI -10.9 to -8.5 cm), systolic blood stress (-3.9 mm Hg, 95% CI -5.8 to -2.0 mm Hg), and Quick Type 36 Model 2 Well being Survey, Acute Model (SF-36) bodily functioning rating (2.5 factors, 95% CI 1.6-3.3).
As to be anticipated with a GLP-1 receptor agonist, about half of sufferers who continued on semaglutide skilled gastrointestinal hostile occasions versus about 26% of these on placebo. Most hostile occasions had been delicate to reasonable, the commonest of which included diarrhea, nausea, and constipation.
That is the fourth and ultimate installment within the section III STEP medical program, constructing upon three earlier trials. The primary trial — STEP 1, printed within the New England Journal of Drugs this February — discovered that sufferers with a BMI of 30 or larger with out diabetes noticed a mean 14.9% lack of baseline physique weight after 68 weeks of remedy.
As for the STEP 2 trial, semaglutide was additionally confirmed efficient in chubby adults with sort 2 diabetes, yielding a mean 9.6% lack of baseline physique weight after 68 weeks. And the third installment on this medical program discovered that semaglutide plus intensive behavioral remedy helped adults with chubby or weight problems lose a mean of 16% of physique weight.
Based mostly on this medical program, Novo Nordisk filed for FDA approval of the two.4-mg weekly dose of semaglutide, in search of a sign for persistent weight administration in December 2020.
Semaglutide is already accessible in a 0.5-mg and 1-mg injectable dose offered below the commerce identify Ozempic, which is indicated for sort 2 diabetes and threat discount of main cardiovascular occasions, together with coronary heart assault, stroke, and loss of life, in adults with sort 2 diabetes with recognized coronary heart illness, which was first authorized in December 2017. And in September 2019, an oral type of semaglutide was authorized in 7-mg and 14-mg tablets, offered below the commerce identify Rybelsus, likewise indicated for sort 2 diabetes.
Novo Nordisk additionally holds approval for liraglutide, one other GLP-1 receptor agonist, offered below the commerce identify Victoza (1.2 or 1.8 mg/day) indicated for sort 2 diabetes. Following this preliminary approval in 2010, liraglutide was later authorized below the identify Saxenda (3 mg/day) in 2014 for persistent weight administration in adults with a BMI of 30 or larger, or a BMI of 27 or larger and at the least one weight-related medical situation.
The trial was funded by Novo Nordisk A/S, Søborg, Denmark.
Rubino reported relationships with Boehringer Ingelheim, AstraZeneca, and Novo Nordisk. Different co-authors additionally reported disclosures.