What the trial was testing
The STEP 1 enrolled 1,961 patients with obesity. The study was sponsored by Novo Nordisk and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
~15% average body weight loss on weekly semaglutide vs. ~2.4% on placebo at 68 weeks.
New England Journal of Medicine · 2021 · NCT03548935
These findings — that average body weight loss on once-weekly semaglutide vs. placebo at 68 weeks — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 1,961 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with obesity, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Semaglutide for weight management is FDA-approved as Wegovy and available now (supply has been tight on and off). It's a once-weekly injection that you give yourself at home. Coverage is the biggest barrier — many insurers don't pay for weight-management indications even though they cover the same drug for diabetes. Ask your doctor about eligibility and check Novo Nordisk's savings programs if you have commercial insurance.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open obesity trials
Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes
The objective of this study is to investigate the impact of hypocaloric time-restricted eating (TRE) at different day times (early versus late TRE) on glucose metabolism and other cardiometabolic parameters in individuals with overweight and with normal, or impaired glucose metabolism (prediabetes and type 2 diabetes). In addition, the study aims to elucidate the molecular mechanisms underlying these effects.
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes
The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.