The US Meals and Drug Administration (FDA) has permitted a 2.4 mg/week subcutaneous dose of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy, Novo Nordisk) for weight reduction.
Particularly, this drug format and dosage are permitted as an adjunct to a reduced-calorie eating regimen and elevated bodily exercise to deal with adults who’ve weight problems (physique mass index [BMI] ≥ 30 kg/m2) or are chubby (BMI ≥ 27 kg/m2) with at the least one weight-related comorbidity.
Semaglutide “induces weight reduction by lowering starvation, rising emotions of fullness, and thereby serving to folks eat much less and cut back their calorie consumption,” in accordance with an organization statement.
“Gamechanger“ Drug Examined in STEP Medical Trial Program
The favorable FDA ruling is predicated on outcomes from the Semaglutide Remedy Impact in Folks With Weight problems (STEP) program of 4 section 3 scientific trials that examined the drug’s security and efficacy in additional than 4500 adults with chubby or weight problems.
The 4 68-week trials of subcutaneous semaglutide 2.4 mg/week versus placebo have been revealed within the New England Journal of Drugs (STEP 1), The Lancet (STEP 2), and JAMA (STEP 3, STEP 4) in February and March 2021.
As beforehand reported by Medscape Medical Information, all trials have been in adults with chubby or weight problems:
STEP 1 was in 1961 adults.
STEP 2 was in 1210 adults who additionally had diabetes.
STEP 3 was in 611 adults, the place these within the remedy group additionally underwent an intensive way of life intervention.
STEP 4 was in 803 adults who had reached a goal dose of two.4 mg semaglutide after a 20-week run-in (and the trial examined additional weight-loss within the subsequent 48 weeks).
Within the STEP 1, 2, and 4 trials of people with chubby and weight problems, these within the semaglutide teams attained a 15% to 18% weight reduction over 68 weeks.
The dosage was well-tolerated. The most typical uncomfortable side effects have been gastrointestinal, and so they have been transient and gentle or reasonable in severity.
A coauthor of the STEP 1 trial, Rachel Batterham, MBBS, PhD, of the Centre for Weight problems Analysis at College Faculty London, UK, stated on the time of publication: “The findings of this examine characterize a serious breakthrough for bettering the well being of individuals with weight problems.”
“No different drug has come near producing this stage of weight reduction — this actually is a gamechanger. For the primary time, folks can obtain by medicine what was solely attainable by weight-loss surgery,” she added.
Decrease-Dose Injectable and Tablet Already Authorized for Diabetes
Subcutaneous semaglutide at doses as much as 1 mg/week (Ozempic, Novo Nordisk), which comes as prefilled pens at doses of 0.5 mg or 1.0 mg, is already permitted for the remedy of kind 2 diabetes.
The corporate can also be making use of for approval for the next dose of semaglutide, 2 mg/week, to be used in kind 2 diabetes, and has simply resubmitted its label enlargement software to the FDA, after the company issued a refusal to file letter in March.
And in September 2019, the FDA approved oral semaglutide (Rybelsus, Novo Nordisk), in doses of seven and 14 mg/day, to enhance glycemic management in kind 2 diabetes, making it the primary GLP-1 receptor agonist accessible in pill kind.
CVOT and Oral Format Trials for Weight problems on the Horizon
The continuing Semaglutide Results on Coronary heart Illness and Stroke in Sufferers With Obese or Weight problems (SELECT) trial will shed light on cardiovascular outcomes after 2.5 to five years in sufferers with heart problems and chubby or weight problems however with out kind 2 diabetes. Individuals will obtain semaglutide in doses as much as a most of two.4 mg/week, or placebo, as an adjunct to way of life suggestions centered on cardiovascular danger discount. The examine is anticipated to finish in 2023.
And Novo Nordisk plans to initiate a world 68-week section 3 trial within the second half of 2021 on the efficacy and security of oral semaglutide 50 mg in contrast with placebo in 1000 folks with weight problems or chubby and comorbidities.