UK’s MHRA approves high-dose Wegovy (semaglutide 7.2 mg) for people with obesity  – 

Based on phase 3b STEP UP trial (n=1,407), in which high-dose semaglutide conferred 21% weight loss

The UK’S Medicines and Healthcare products Regulatory Agency (MHRA) announced today that it has approved Novo Nordisk’s 7.2 mg dose of Wegovy for adults with obesity. The 7.2 mg dose will be delivered as three injections of semaglutide 2.4 mg.

The decision was based on the phase 3b STEP UP trial (n=1,407), which demonstrated that the 7.2 mg dose can deliver 21% weight loss, comparable to Lilly’s Zepbound (tirzepatide). The MHRA stated that the three injections are indicated for people with obesity (BMI ≥30 kg/m2) and not for overweight patients using Wegovy to lower cardiovascular risk. If people who are overweight could also take the higher dose and avoid cardiovascular disease, we assume this would also create system savings as well as greater patient well-being. From a clinical perspective, we are curious if the average patient taking one shot a week will move to three shots a week, taken on different days or the same day. At JPM 2026, Novo Nordisk leadership emphasized that pursuing regulatory approval for high‑dose Wegovy will be the company’s top priority for OUS markets in 2026.

Semaglutide 7.2 mg conferred 20.7% weight loss in the phase 3 STEP UP trial

The phase 3b STEP UP trial (n=1,407) evaluated high-dose semaglutide (7.2 mg) in people with overweight or obesity without T2D.

Assuming that all participants adhered to treatment, semaglutide 7.2 mg achieved weight loss of nearly 21% at Week 72 (vs. 17.5% with semaglutide 2.4 mg, 2.4% with placebo), from a mean baseline body weight of 113 kg (249 lbs). The safety and tolerability profiles were similar to those of semaglutide 2.4 mg.

In December 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for semaglutide 7.2 mg, with potential approval in the EU expected early next year.

High‑dose Wegovy becomes Novo Nordisk’s priority for OUS growth in 2026

At JPM Day #2, Novo Nordisk CEO Mr. Maziar Mike Doustdar emphasized the company’s goal to reframe the market’s perception of semaglutide. He said that the company initially took a cautious approach by launching the 2.4 mg dose after it demonstrated 15-16%weight loss – a significant improvement in efficacy from the only comparator at the time, GLP-1 RA Saxenda (liraglutide).

Mr. Doustdar emphasized that the weight loss profile of semaglutide 7.2 mg allows Novo Nordisk to reposition semaglutide among “next generation” incretin-based therapies, including Zepbound. In an interview at JPM, EVP Mr. Emil Kongshøj Larsen added that Novo Nordisk will be “particularly busy” with high-dose Wegovy launches outside the US.

Oral GLP-1 RA awaits UK regulatory response as initial uptake in the US is high

Novo Nordisk is awaiting a UK decision on its oral Wegovy (once-daily semaglutide 25 mg) formulation, which was approved in the US in December 2025 and launched in over 70,000 pharmacies earlier this month. Early US prescription data show that there were 3,071 retail prescriptions for oral Wegovy in the first four days, not including fills through NovoCare Pharmacy, suggesting actual numbers may be higher.

Close Concerns’ Questions

  1. How quickly will the UK integrate the 7.2 mg dose into clinical practice?
  2. What proportion of current 2.4 mg users will escalate to 7.2 mg, and how “tolerable” will this be? What titration strategies will clinicians suggest in order to avoid tolerability issues (nausea, GI side effects, etc.)?
  3. Even though 2.4 mg is the highest dose currently used in Wegovy pens, is it possible to produce injectable pens for higher doses? Or, will patients take three injections of the highest (current) dose of 2.4 mg at one time? Or will some take a 2.4 mg dose once every couple of days to get to the equivalent of three times each week?
  4. In practical terms, how does the average patient view moving from a “once-weekly” medicine back to, not a daily medicine, but a medicine taken three times a week?
  5. Would the average patient perceive it as easier to take three injections at one time, or would it be easier to take three injections a week, each on, for example, Monday, Wednesday, and Friday? Is there a risk of someone deciding that taking three shots on different days is too confusing to remember? If some patients find it easiest to take a 2.4 mg shot every other day (thereby taking 36 mg per month), what might the impact be on adherence? Would they lose more weight because they are taking a higher dose or because they might find it easier to be more adherent?
  6. How will oral Wegovy’s launch interact with high-dose injectable uptake in the UK and globally?
  7. What is the limit to the highest daily, weekly, and monthly doses that can be tolerated?
  8. Does titration work best and fastest with a once-daily (like Victoza)?

--by Kayla Mathieu, Kat Moon, Monica Oxenreiter, and Kelly Close

UK’s MHRA approves high-dose Wegovy (semaglutide 7.2 mg) for people with obesity -
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