SURMOUNT trial programme (revision 9)
Old revision·23:17, 6 Nov 2024·OpenLabelOtto
| SURMOUNT trial programme | |
|---|---|
Weight change by dose in the principal obesity trial. | |
| Drug | Tirzepatide 5, 10 and 15 mg weekly |
| Indication | Chronic weight management |
| Principal duration | 72 weeks |
| Topic infobox · conventions | |
The SURMOUNT trial programme is the phase 3 series that established tirzepatide for chronic weight management. SURMOUNT-1 randomised 2,539 adults with obesity and without diabetes to tirzepatide 5, 10 or 15 mg weekly or placebo for 72 weeks.[1]
Mean weight change was −15.0%, −19.5% and −20.9% at the three doses against −3.1% on placebo. Both arms received lifestyle counselling, so the placebo figure is not a no-treatment baseline; see Placebo-adjusted effect.[1]
SURMOUNT-2 studied participants with obesity and type 2 diabetes and reported smaller reductions — −12.8% and −14.7% at 10 and 15 mg against −3.2% — reproducing the attenuation of weight response in diabetes seen across this field.[2]
Constituent trials
[edit]| Trial | Population | Duration | Result at highest dose |
|---|---|---|---|
| SURMOUNT-1 | Obesity, no diabetes | 72 weeks | −20.9% vs −3.1% |
| SURMOUNT-2 | Obesity with type 2 diabetes | 72 weeks | −14.7% vs −3.2% |
| SURMOUNT-3 | After intensive lifestyle lead-in | 72 weeks | Further loss after lead-in |
| SURMOUNT-4 | Randomised withdrawal after lead-in | 88 weeks total | Regain on withdrawal |
SURMOUNT-4 is the counterpart of STEP 4 and addresses the same question: what happens when treatment stops. Participants randomised to placebo after a lead-in regained a substantial proportion of the weight lost. See Weight regain after discontinuation.[2]
SURMOUNT-3 shows that a lifestyle lead-in does not exhaust the available effect: participants who had already lost weight on intensive lifestyle intervention lost further weight on active treatment.[1]
References
- ^ a b c Jastreboff AM, Aronne LJ, Ahmad NN, et al. "Tirzepatide once weekly for the treatment of obesity." New England Journal of Medicine 387(3):205–216 (2022). DOI:10.1056/NEJMoa2206038. PMID 35658024.
- ^ a b Garvey WT, Frias JP, Jastreboff AM, et al. "Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2)." The Lancet 402(10402):613–626 (2023). PMID 37385275.