Novo Nordisk Launches Late-Stage Trial to Find the Lowest Effective Dose of Oral Wegovy
Key Takeaways:
- Novo Nordisk has begun OASIS-5, a 60-week late-stage trial testing lower maintenance doses of the oral Wegovy pill.
- The trial will enrol 450 adults with a BMI of 30 or above, or 27 with a weight-related health condition.
- Interest in lower dosing reflects real-world practice, where cost and side effects already drive some people to take reduced doses.
A trial built around dose flexibility
Danish drugmaker Novo Nordisk has started testing smaller doses of its Wegovy pill in a new late-stage study designed to identify the lowest dose that still supports weight loss, according to a listing on a US clinical trials database.
The study, known as OASIS-5, began on 12 August and is scheduled to run until 2028. It will examine lower strengths of the daily maintenance dose – the dose used to sustain weight loss once it has been achieved, rather than the escalating doses used at the start of treatment. At present, the approved long-term dose of the Wegovy pill is 25 milligrams.
“Having a broader range of maintenance doses could provide greater flexibility in treatment and optimising the patient experience,” Novo said in an emailed statement to Reuters.
Novo has not specified which new dose strengths are being tested. The Wegovy pill is also approved in doses of 1.5 mg, 4 mg and 9 mg.
What OASIS-5 will measure
The 60-week trial will recruit 450 adult participants who have previously struggled to lose weight, with a Body Mass Index of 30 or above, or 27 in combination with a weight-related health issue.
The primary objective is to establish whether lower doses of oral semaglutide – the active ingredient in Wegovy – produce greater weight loss than placebo over the 60-week period. Secondary objectives include changes in waist circumference, other health benefits and the side effect profile at these reduced strengths.
The study will exclude people living with diabetes, those who have experienced recent major weight changes, and anyone currently being treated with GLP-1 medications.
Seeking health benefits beyond weight loss
The trial arrives against a backdrop of dosing behaviour that is already happening outside clinical protocols. Some people taking GLP-1 medicines, including Wegovy and Lilly’s Zepbound injections, are microdosing or otherwise taking lower-than-approved doses. The practice has become popular largely because of the high cost of the medicines and the side effects associated with them.
“People are using low dosages of these products… they just decide on their own,” Novo CEO Mike Doustdar told Reuters in an interview last week, noting that patients often seek health benefits beyond weight loss.
That observation points to a broader question facing prescribers: what people hope to gain from GLP-1 therapy is not always confined to the number on the scales. Understanding the pharmacology behind dose escalation and maintenance, and being able to discuss the trade-offs between efficacy, tolerability and cost, is increasingly central to safe prescribing. It is a theme covered directly in the College of Contemporary Health’s CPD short course GLP-1RAs in Practice: Prescribing, which examines dose titration, monitoring and shared decision-making in day-to-day clinical settings.
Competitive pressure in a growing market
Novo is under pressure after losing ground to US rival Eli Lilly in an obesity drug market projected to exceed $100 billion by 2030. Investors are watching the Wegovy pill closely; it generated second-quarter sales of 3.22 billion Danish kroner ($499.89 million).
Doustdar expects market segmentation to prevent a winner-take-all contest with Lilly – a view consistent with a future in which different doses, formulations and treatment goals serve different groups of people rather than a single product dominating.
Lilly did not immediately respond to a Reuters request for comment on whether it plans to test smaller doses of its oral drug Foundayo, which has lowest approved doses of 0.8 mg and 2.5 mg.
What this could mean for practice
If OASIS-5 demonstrates that lower maintenance doses deliver meaningful weight loss, it would give clinicians a wider set of options for people who cannot tolerate higher strengths, who are managing the cost of long-term therapy, or who have reached a weight they wish to maintain rather than continue reducing. It would also bring an existing real-world practice within the evidence base, replacing self-directed dose reduction with an approved, monitored alternative.
Results are not expected until 2028, so any change to prescribing practice remains some way off. In the meantime, conversations about dosing, expectations and adherence will continue to sit with the healthcare professionals supporting people through treatment.
CCH insight
Dose selection, titration and tolerability are among the most common practical challenges in GLP-1 prescribing. The College of Contemporary Health’s CPD short course GLP-1RAs in Practice: Prescribing covers dose escalation and maintenance, managing side effects, patient selection and monitoring – equipping healthcare professionals to make confident, evidence-based decisions as the treatment landscape evolves.
Explore GLP-1RAs in Practice: Prescribing →
Source: Reuters
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