Élan Clinical Evidence Update: July 2026
What Changed in the Past Month

1. Wegovy gained a new UK indication for MASH

On July 3, the UK medicines regulator approved Wegovy to treat metabolic-associated steatohepatitis, or MASH, in adults with moderate-to-advanced liver fibrosis. The authorisation is conditional because further confirmatory evidence is still required. Availability through the NHS is a separate decision and had not yet been confirmed.

Why it matters: semaglutide is moving beyond weight management into disease-specific treatment. This approval applies in the UK and should not be assumed to apply automatically in Estonia, Finland or the wider EU.

2. The EU did not grant Mounjaro a new cardiovascular indication

The European Medicines Agency completed its review of an application to extend Mounjaro's use to reducing serious cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. The committee did not recommend granting the new indication, but agreed that relevant trial data should be added to the product information.

Why it matters: favourable data and a formal indication are not the same thing. The decision does not prove that tirzepatide lacks cardiovascular benefit. It means the evidence did not lead to the requested new EU indication.

3. Eye-risk evidence became clearer, but not definitive

Two large observational studies published in Annals of Internal Medicine examined ischaemic optic neuropathy among people with type 2 diabetes. Both found a higher relative risk with GLP-1 medicines than with comparison diabetes medicines, but the absolute event rate remained very low. In the US study, the estimated 18-month difference was roughly 3 additional cases per 10,000 patients. In the Swedish study, the difference became smaller when researchers restricted the analysis to patients using metformin, suggesting that diabetes severity and other confounding may explain part of the signal.

Why it matters: this is a safety signal, not proof of causation. Sudden vision loss still requires urgent assessment. The studies do not support routine discontinuation in patients without symptoms.

4. Semaglutide reduced food intake even when the feeling changed

A 60-week randomised trial of 120 adults found that semaglutide 2.4 mg reduced energy intake at laboratory meals at weeks 20, 40 and 60. Participants ate roughly 240 to 292 fewer calories than those receiving placebo at the measured meals. However, differences in subjective appetite were no longer significant at weeks 40 and 60.

Why it matters: treatment may still affect intake even when the early feeling of strong appetite suppression becomes less noticeable. A change in sensation does not by itself prove that the medicine has stopped working.

5. Pregnancy data were cautiously reassuring, but certainty remains low

A systematic review and meta-analysis of seven cohort studies, covering more than 40,000 reported GLP-1-exposed pregnancies, did not find a statistically significant increase in major congenital malformations, stillbirth, miscarriage, small-for-gestational-age birth or preterm birth. The authors rated the overall certainty as low, and one urinary-malformation signal was based on unadjusted data.

Why it matters: the findings may offer some reassurance after unintended exposure. They are not evidence that GLP-1 treatment should be started or deliberately continued during pregnancy. Current product-specific pregnancy guidance still applies.

6. A small study exposed a nutrition gap during treatment

The prospective CRAVE study followed 28 adults starting semaglutide or tirzepatide for 24 weeks without structured nutrition support. Weight and fat mass fell, but estimated skeletal muscle mass and several nutrient intakes also declined. Diet quality and overall food cravings did not improve significantly. Because the study was small, observational and used bioelectrical impedance, the findings are exploratory rather than definitive.

Why it matters: eating less is not automatically the same as eating well. Protein adequacy, nutrient density, resistance exercise and monitoring of strength remain part of responsible weight-loss care.

7. Another oral GLP-1 medicine entered the evidence pipeline

In a sponsor-funded phase 2 trial, the oral small-molecule GLP-1 medicine HRS-7535 was studied in 235 Chinese adults with obesity and without diabetes. At 26 weeks, the highest-dose group lost 9.36% of body weight on average, compared with 2.50% with placebo. Gastrointestinal adverse effects were the most common.

Why it matters: oral obesity medicines may eventually broaden treatment choice. HRS-7535 is not an approved treatment, and a short phase 2 trial cannot establish long-term safety, durability or performance in wider populations.

Safety signal to watch: tirzepatide reports

A new analysis of the US FDA adverse-event reporting database found prominent reports involving medication errors, injection-site reactions and gastrointestinal symptoms with tirzepatide. It also identified less established signals, including starvation ketoacidosis, that require further investigation. Reporting databases cannot measure incidence or prove that the medicine caused an event.

Élan view: this does not create a new rule for every patient. It strengthens the case for correct device use, adequate intake, early side-effect review and avoiding aggressive self-directed restriction.

What this month does not change

• Do not start, stop, restart or change a dose because of a headline.
• Use product information for the country and medicine actually prescribed.
• New safety signals should be discussed in absolute terms, not used to create panic.
• Weight loss still needs a maintenance plan that protects nutrition, strength and long-term follow-up.

Primary and official sources