Human randomized trialNew England Journal of Medicine · 2022

Tirzepatide once weekly for the treatment of adults with overweight or obesity

Phase 3, randomized, double-blind, placebo-controlled dose-ranging trial (SURMOUNT-1).

Primary source

DOI: 10.1056/NEJMoa2206038

Who or what was studied.

Adults with obesity (BMI ≥ 30), or overweight (BMI ≥ 27) with at least one weight-related comorbidity, excluding diabetes.2,539 randomized participants.72 weeks of treatment and follow-up.

Main findings.

Over 72 weeks, participants randomized to tirzepatide 15 mg once weekly had a mean body-weight change of −20.9%, versus −3.1% with placebo. The 5 mg and 10 mg doses produced mean changes of −15.0% and −19.5%, respectively. All tirzepatide dose groups met the prespecified primary and key secondary weight-loss objectives.

Limitations.

Key limitations: the 72-week treatment window does not establish long-term safety or durability of effect; exclusion criteria limit generalizability to broader or more medically complex populations; and the trial compared tirzepatide with placebo rather than with other active treatments. Gastrointestinal adverse events were the most common reason for discontinuing tirzepatide.

Compounds & topics.

tirzepatideobesitybody compositionmetabolic research

For plain-language guides on these compounds, see the peptide hub and the peptide encyclopedia.

Back to the study library