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Trial protocolFat loss and metabolism

Tirzepatide weekly, the SURMOUNT-1 escalation

Weight loss in adults with obesity or overweight and no 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
5 mg, 10 mg or 15 mg at maintenance, by randomised assignment
Frequency
Once weekly
Route
Subcutaneous injection
Duration
72 weeks in the primary treatment period

How it was reached, step by step

  1. 01

    2.5 mg once weekly to start

  2. 02

    Increases of 2.5 mg every four weeks

  3. 03

    Escalation stops at the assigned maintenance dose of 5 mg, 10 mg or 15 mg

  4. 04

    That dose is then held to week 72

What was measured

Percentage change in body weight at week 72 and the proportion reaching a reduction of at least 5 percent, both co-primary. Body composition, waist circumference and cardiometabolic measures were secondary.

What was reported

Results as the trial reported them, with their comparators.

  • Mean weight change at 72 weeks was -15.0 percent on 5 mg, -19.5 percent on 10 mg and -20.9 percent on 15 mg, against -3.1 percent on placebo.

  • 2,539 adults were randomised. The three tirzepatide arms differ from each other, which is the part of this trial worth reading: the dose changed the result.

  • Gastrointestinal adverse events were the commonest and were mostly reported during escalation rather than at maintenance.

Where this comes from

Jastreboff et al., Tirzepatide Once Weekly for the Treatment of Obesity, New England Journal of Medicine, 2022. A phase 3 randomised controlled trial funded by Eli Lilly.

The escalation rule above is the one published in the trial registration arm descriptions, which state a 2.5 mg start and 2.5 mg increments every four weeks up to each assigned maintenance dose.

What this protocol cannot tell you

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

Weight was the endpoint. This trial did not measure heart attacks, strokes or deaths, and the cardiovascular indication tirzepatide later received rests on a different trial in a different population. Everyone here was supported by a lifestyle programme and monitored by a trial team, and people with diabetes were excluded. The escalation is a tolerability device rather than a target, and a person who cannot hold the assigned maintenance dose has no number in this table that belongs to them.

The compounds in this protocol

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

  • Tirzepatide

    A first-in-class dual GIP and GLP-1 receptor agonist with superior weight loss and glycemic control versus GLP-1 mono-agonists.

Other trial protocols in the registry

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