Semaglutide · 2021
STEP 1 Question: Weight change
Population Adults with overweight/obesity without diabetes Design Randomized, double-blind, placebo-controlled Follow-up 68 weeks Endpoint Percent change in body weight and achieving at least 5% loss Lifestyle intervention accompanied both groups; this is not a head-to-head drug comparison.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 33567185 DOI: 10.1056/NEJMoa2032183
Semaglutide · 2021
STEP 2 Question: Weight change
Population Adults with overweight/obesity and type 2 diabetes Design Randomized, double-blind, double-dummy, placebo-controlled Follow-up 68 weeks Endpoint Percent change in body weight and achieving at least 5% loss Diabetes population; results should not be substituted for STEP 1 or compared as if randomized across trials.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 33667417 DOI: 10.1016/S0140-6736(21)00213-0
Semaglutide · 2021
STEP 3 Question: Weight change
Population Adults with overweight/obesity without diabetes Design Randomized, double-blind, placebo-controlled, with intensive behavioral therapy Follow-up 68 weeks Endpoint Percent change in body weight and achieving at least 5% loss Initial low-calorie diet and intensive behavioral support limit comparisons with less intensive programs.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 33625476 DOI: 10.1001/jama.2021.1831
Semaglutide · 2021
STEP 4 Question: Weight maintenance
Population Adults reaching the maintenance dose after a semaglutide run-in Design Randomized withdrawal: continue semaglutide versus switch to placebo Follow-up 20-week run-in; 48-week randomized period Endpoint Body weight change during the randomized period An enriched run-in population; this is not a trial of starting therapy in all eligible people.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 33755728 DOI: 10.1001/jama.2021.3224
Semaglutide · 2023
SELECT Question: Cardiovascular events
Population Adults aged at least 45 with established cardiovascular disease and overweight/obesity, without diabetes Design Randomized, double-blind, placebo-controlled, event-driven Follow-up Mean follow-up 39.8 months Endpoint Cardiovascular death, nonfatal myocardial infarction or nonfatal stroke Secondary prevention population; this does not establish benefit for every person seeking weight loss.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 37952131 DOI: 10.1056/NEJMoa2307563
Tirzepatide · 2022
SURMOUNT-1 Question: Weight change
Population Adults with overweight/obesity without diabetes Design Randomized, double-blind, placebo-controlled Follow-up 72 weeks Endpoint Percent change in body weight and achieving at least 5% loss Separate treatment groups and lifestyle support; do not compare raw percentages with another trial as a randomized contrast.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 35658024 DOI: 10.1056/NEJMoa2206038
Tirzepatide · 2023
SURMOUNT-2 Question: Weight change
Population Adults with overweight/obesity and type 2 diabetes Design Randomized, double-blind, placebo-controlled Follow-up 72 weeks Endpoint Percent change in body weight and achieving at least 5% loss Diabetes population and specified study regimens; not interchangeable with SURMOUNT-1.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 37385275 DOI: 10.1016/S0140-6736(23)01200-X
Tirzepatide · 2023
SURMOUNT-3 Question: Weight change
Population Adults without diabetes who lost at least 5% during intensive lifestyle intervention Design Randomized, double-blind, placebo-controlled after lifestyle lead-in Follow-up 12-week lead-in; 72-week randomized treatment Endpoint Weight change after randomization and achieving at least 5% further loss Selected lifestyle responders; total change from lead-in and change after randomization are different quantities.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 37840095 DOI: 10.1038/s41591-023-02597-w
Tirzepatide · 2024
SURMOUNT-4 Question: Weight maintenance
Population Adults with overweight/obesity without diabetes after a tirzepatide lead-in Design Randomized withdrawal: continue tirzepatide versus switch to placebo Follow-up 36-week lead-in; 52-week randomized period Endpoint Percent change in body weight during the randomized period Run-in selection and withdrawal design; not a trial of starting treatment or an individualized stopping plan.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 38078870 DOI: 10.1001/jama.2023.24945
Tirzepatide + Semaglutide · 2025
SURMOUNT-5 Question: Direct weight comparison
Population Adults with overweight/obesity without diabetes Design Randomized, open-label, active-controlled head-to-head Follow-up 72 weeks Endpoint Percent change in body weight; waist circumference Open-label study with specific maximum tolerated regimens. Does not determine which treatment fits an individual.
Human study · Published results; registry recruitment status not assessed. Source checked 2026-11-12.
Primary publication record · PMID 40353578 DOI: 10.1056/NEJMoa2416394