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Trial protocolFat loss and metabolism

Semaglutide 2.4 mg weekly, the STEP 1 escalation

Weight loss in adults with overweight or obesity who do not have diabetes

The schedule a registered trial actually ran, taken from the paper and the trial registration rather than from a label summary. Every one carries a PubMed or ClinicalTrials record you can open.

Not advice. This is a record of a schedule, not a dose for you.

The schedule, as reported

Each field below is what the source states, not a rounded version of it. Where the source does not publish a detail, the field says so instead of filling the gap.

Amount
2.4 mg at maintenance, reached through a 16 week escalation
Frequency
Once weekly
Route
Subcutaneous injection
Duration
68 weeks including the escalation

How it was reached, step by step

  1. 01

    0.25 mg once weekly, weeks 1 to 4

  2. 02

    0.5 mg once weekly, weeks 5 to 8

  3. 03

    1.0 mg once weekly, weeks 9 to 12

  4. 04

    1.7 mg once weekly, weeks 13 to 16

  5. 05

    2.4 mg once weekly, weeks 17 to 68

What was measured

Percentage change in body weight from baseline to week 68, and the proportion losing at least 5 percent of body weight, both co-primary. Absolute weight in kilograms, cardiometabolic risk factors and participant reported physical functioning were secondary.

What was reported

Results as the trial reported them, with their comparators.

  • Mean body weight change at week 68 was -14.9 percent on semaglutide against -2.4 percent on placebo, an estimated treatment difference of -12.4 percentage points (95 percent CI -13.4 to -11.5).

  • 1,047 participants on semaglutide (86.4 percent) lost at least 5 percent against 182 on placebo (31.5 percent). At least 15 percent was reached by 50.5 percent against 4.9 percent.

  • Absolute change was -15.3 kg against -2.6 kg, an estimated difference of -12.7 kg.

  • Nausea and diarrhoea were the commonest adverse events and were typically transient. 4.5 percent of the semaglutide group stopped treatment for gastrointestinal events against 0.8 percent on placebo.

Where this comes from

Wilding et al., Once-Weekly Semaglutide in Adults with Overweight or Obesity, New England Journal of Medicine, 2021. 1,961 adults randomised 2 to 1, funded by Novo Nordisk.

The week by week escalation above is the schedule written into the trial registration, not a reconstruction from the prescribing label. The two happen to agree, and the registration is the primary record.

What this protocol cannot tell you

Required on every entry in this registry, and never empty.

Every participant also received lifestyle counselling, so the schedule was never tested on its own and the drug cannot be separated from the programme around it. The trial excluded people with diabetes, so the numbers do not transfer to them. 68 weeks says nothing about year three, and the trial measured weight rather than any outcome a person cares about underneath it. The escalation exists because the drug is hard to tolerate, and 4.5 percent still stopped for gut side effects with a trial team monitoring them.

The compounds in this protocol

Each profile carries the full evidence record, the legal status and what the trials did not show.

  • Semaglutide

    A long-acting GLP-1 receptor agonist approved for type 2 diabetes and chronic weight management, with proven cardiovascular risk reduction.

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