A third of participants trialing a new 7.2mg “higher dose” of semaglutide – licensed as Wegovy for weight loss – lost a quarter (25%) or more of their body weight after 72 weeks on the drug compared to placebo, Novo Nordisk today (June 21) revealed.
The pharmaceutical manufacturer announced the results of its randomised and double-blind “step up trial”, which tested a once-a-week Wegovy dose that is three times higher than its highest currently approved dose, at the American Diabetes Association (ADA) scientific sessions in Chicago.
Some 1,407 adults “with BMI ≥30 kg/m2 without diabetes” were included in the trial, it said.
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It found that after almost a year and a half on the drug, patients who adhered to treatment experienced a “mean weight loss of 20.7%…of their body weight”.
This compared with an average 17.5% weight loss with the 2.4mg dose and 2.4% with the placebo, it said.
Last month, a head-to-head clinical trial by Mounjaro manufacturer Eli Lily claimed its tirzepatide-based jab is “superior” to Wegovy’s semaglutide-based formula – with Mounjaro achieving a weight reduction of 20.2% after 72 weeks of treatment, compared with a 13.7% reduction from Wegovy.
“Adverse events”
However, Novo Nordisk today admitted that participants on the new 7.2mg dose were more likely to “[discontinue] due to gastrointestinal adverse events” than those on its current 2.4mg dose – with the trial finding 3.3% and 2% discontinue rates respectively.
“The most common adverse events were gastrointestinal,” it said, adding that the “vast majority were mild to moderate during dose escalation and diminished over time”.
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And it confirmed that “an application for a label update for the 7.2mg dose of Wegovy is expected to be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) shortly”.
Novo Nordisk UK’s general manager Sebnem Avsar Tuna said the higher dose “achieved greater weight loss than previously seen with a comparable safety and tolerability profile to the 2.4mg once-weekly dose”.
“Obesity is a chronic disease and with these results, semaglutide reaffirms its weight loss potential for people living with obesity,” she added.
NHS Mounjaro service
The news comes as a first cohort of patients will be eligible to receive tirzepatide – known as Mounjaro – via the NHS from Monday (June 23), according to the Company Chemists’ Association (CCA).
But the pharmacy membership body’s chief executive Malcolm Harrison warned that “it is unlikely that the planned GP provision will be sufficient to meet patient demand”.
“Building on the expertise developed through private weight loss services, community pharmacies would be well placed to deliver wraparound weight loss care to increase access where needed,” he stressed.
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Meanwhile, C+D last week exclusively revealed that glucagon-like peptide-1 receptor agonists (GLP-1 RA) medicines – including Wegovy and Mounjaro – had been linked to 111 deaths by the end of May.
But a week earlier, the chief pharmaceutical officer (CPhO) for England told C+D that there is a “really significant opportunity” for community pharmacy in new weight loss jab services at the NHS Confed Expo in Manchester.
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Also speaking on weight loss drugs in a separate session at the conference, NHS England (NHSE) national medical director Sir Stephen Powis stressed that “we are at the very early stages of learning how to use these drugs” and “there is more to learn”.
And health minister Karin Smyth this month said that the General Pharmaceutical Council (GPhC) has the government’s “full” backing to “tackle the misuse of weight loss medications”.
