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Randomized controlled trial

OASIS 1: oral semaglutide 50 mg, a daily pill, for obesity

At 68 weeks, weight changed by −15.1% with oral semaglutide 50 mg and −2.4% with placebo; the estimated difference was −12.7 percentage points (95% CI, −14.2 to −11.3).

Knop FK et al. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet, 2023. DOI: 10.1016/S0140-6736(23)01185-6

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Key facts

Drug
semaglutide
Design
Randomized controlled trial
Participants
667
Duration
68 weeks
Funding
Novo Nordisk
Registry
NCT05035095
Population
667 adults without type 2 diabetes with a BMI of 30 or more, or 27 or more with weight-related complications or comorbidities, at 50 outpatient clinics in nine countries in Asia, Europe and North America, randomized to oral semaglutide 50 mg (334) or placebo (333).
Primary outcome
Percentage change in body weight and proportion reducing their weight by at least 5% at 68 weeks with daily oral semaglutide, escalated to 50 mg, versus placebo, both with a lifestyle intervention.

What it found

Mean weight loss, % of starting weight · 68 weeks
  • Oral semaglutide 50 mg daily (pill)−15.1%
  • Placebo−2.4%

Difference: −12.7 points vs placebo (95% CI, −14.2 to −11.3).

Figures from the paperSee the results in a chart

At 68 weeks, weight changed by −15.1% with oral semaglutide 50 mg and −2.4% with placebo; the estimated difference was −12.7 percentage points (95% CI, −14.2 to −11.3). Weight fell by at least 5% in 85% on semaglutide and 26% on placebo, by at least 10% in 69% and 12%, by at least 15% in 54% and 6%, and by at least 20% in 34% and 3%. The main analysis included everyone who was randomized, whether or not they stopped treatment or used other weight-loss therapies (intention-to-treat analysis). Digestive adverse effects, mostly mild or moderate, affected 80% on semaglutide and 46% on placebo.

Limitations

Funded by Novo Nordisk. People with type 2 diabetes were excluded. It studied a daily dose of 50 mg, different from the 25 mg dose evaluated in OASIS 4, and it was not compared with injectable semaglutide. The percentages of participants reaching each threshold were calculated among those with data at 68 weeks (317 on semaglutide and 295 on placebo).

What it means for you

Semaglutide as a pill, at a high dose of 50 mg daily, reduced weight by an average of 15.1% over 68 weeks in people without diabetes, with frequent digestive side effects. That dose differs from the one studied in other oral semaglutide trials, and it was not compared with the injection. If you prefer an oral option, ask your doctor which doses and forms are authorized.

Further reading

Related trials

  • semaglutide64 weeks

    OASIS 4

    Weight changed by −13.6% with oral semaglutide 25 mg and −2.2% with placebo at 64 weeks.

  • semaglutide68 weeks

    OASIS 2

    At 68 weeks, weight changed by −14.3% with oral semaglutide 50 mg and −1.3% with placebo.

  • semaglutide72 weeks

    STEP UP

    At 72 weeks, weight changed by −18.7% with semaglutide 7.2 mg, −15.6% with 2.4 mg and −3.9% with placebo.

  • semaglutide120 weeks

    STEP 1 (extension)

    From week 0 to week 68, weight fell by an average of 17.3% with semaglutide and 2.0% with placebo.

Sources

The original paper and the records consulted for this summary, with the date they were accessed.

  1. The Lancet.Knop FK, et al. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;402(10403):705-719.accessed .
  2. National Library of Medicine (PubMed).PubMed record PMID 37385278 (abstract).accessed .