Protocol Reference
Semaglutide
Semaglutide 2.4 mg weekly — approved escalation schedule
Summarise the dose-escalation schedule established by the approved prescribing label and the STEP phase 3 programme for chronic weight management.
FDA Approved for Specific IndicationReviewed September 1, 2026
Research Context
- Source of this information
- This protocol exists because semaglutide completed full clinical development. The schedule below is a summary of published label information, not individualised guidance.
- Evidence level
- Grade A — established in randomised phase 3 trials and reflected in an approved label
- Population studied
- Adults with obesity, or overweight with at least one weight-related comorbidity, in the STEP trials.
- Duration studied
- 68 weeks in STEP 1; approved labelling describes ongoing use with periodic review.
- Route reported
- Subcutaneous injection, once weekly
Protocol as Reported
- 01The approved label describes a graded escalation over roughly 16 weeks, beginning at 0.25 mg once weekly and increasing at four-week intervals through 0.5 mg, 1 mg and 1.7 mg to a maintenance dose of 2.4 mg once weekly.
- 02Escalation is described as tolerability-driven: labelling notes that escalation may be delayed if gastrointestinal effects are not tolerated.
- 03The STEP trials paired the drug with lifestyle intervention, including reduced-calorie diet and increased physical activity, in both treatment and placebo arms.
- 04Trial protocols specified discontinuation criteria and monitoring, including pancreatitis assessment and gallbladder symptom review.
Adverse Events Reported
- Nausea, vomiting, diarrhoea and constipation were the most frequent trial events.
- Gallbladder disorders and pancreatitis were reported; labelling carries specific warnings.
- US labelling carries a boxed warning for thyroid C-cell tumours based on rodent data.
Limitations
- A label schedule is a population-level framework, not a personal dose.
- Trial participants received structured lifestyle support that most people using the drug outside trials do not.
- Weight regain after discontinuation has been documented.
Sources
- Prescribing label
Semaglutide prescribing information
- Randomised controlled trial2021
Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1)
New England Journal of Medicine
Educational reference only. Peptide Atlas does not provide medical advice or individualised dosing guidance, and nothing on this page should be used to guide personal use.