Semaglutide 7.2 mg beat placebo on weight and blood sugar in obesity plus type 2 diabetes trial
A higher 7.2 mg weekly dose of semaglutide helped adults with obesity and type 2 diabetes lose more weight than placebo, but the dose is not approved and its availability has not been disclosed.
Adults who have both obesity and type 2 diabetes and took a once-weekly 7.2 mg dose of semaglutide lost an average of 13.2% of their body weight over 72 weeks, compared with 3.9% for those taking placebo, in a phase 3b trial called STEP UP T2D published in The Lancet Diabetes & Endocrinology in 2025 [1].
The 7.2 mg dose is a new, higher maintenance dose. Semaglutide 2.4 mg is the dose approved for weight management in adults with obesity or overweight who also have at least one weight-related condition, and the trial authors note that many people with obesity and type 2 diabetes do not reach their weight-reduction goals on that dose [1].
The trial randomly assigned 512 adults at 68 hospitals, specialist clinics and medical centers in Bulgaria, Canada, Hungary, Poland, Portugal, Slovakia, South Africa and the United States between Jan. 4 and May 4, 2023 [1]. All participants had a body mass index of at least 30 and an HbA1c between 7.0% and 10.0% [1]. They were assigned in a 3:1:1 ratio to once-weekly semaglutide 7.2 mg (307 people), semaglutide 2.4 mg (103 people) or placebo (102 people), each given alongside a lifestyle intervention, for 72 weeks [1].
At the start, 51.8% of participants were female, the average age was 56, average body weight was 110.1 kg, average BMI was 38.6 and average HbA1c was 8.1% [1].
The two main measures were percentage change in body weight and the share of participants losing at least 5% of their body weight, both comparing 7.2 mg with placebo [1]. On average, the 7.2 mg dose produced 9.3 percentage points more weight loss than placebo (95% CI 7.7 to 11.0 percentage points; p<0.0001) [1]. Odds ratios for reaching weight reductions of at least 5%, 10%, 15% and 20% were 10.0 (95% CI 6.0 to 16.9), 11.3 (5.9 to 21.4), 8.1 (3.7 to 17.7) and 12.3 (3.0 to 51.0), with p values from less than 0.0001 to 0.0006 [1]. Waist circumference fell by an estimated 6.5 cm more with 7.2 mg than with placebo (95% CI 4.1 to 9.0 cm) and HbA1c fell by an estimated 1.5 percentage points more (95% CI 1.2 to 1.8 percentage points), both p<0.0001 [1].
Gastrointestinal side effects were reported by 163 of 307 participants (53.1%) taking semaglutide 7.2 mg, 53 of 103 (51.5%) taking 2.4 mg and 26 of 102 (25.5%) taking placebo [1]. Serious adverse events were reported by 28 people (9.1%) on 7.2 mg, nine (8.7%) on 2.4 mg and nine (8.8%) on placebo [1]. The risk of level 2 to 3 hypoglycemia was low and similar across the three groups [1]. Dysaesthesia was reported by 58 of 307 people (18.9%) taking 7.2 mg, five of 103 (4.9%) taking 2.4 mg and none taking placebo; the authors described safety and tolerability as comparable between the two semaglutide doses except for that imbalance, which they said needs further study [1].
Why it matters for patients
The results apply to a specific group: adults with a BMI of at least 30 and type 2 diabetes averaging an HbA1c of 8.1%, which is above the usual treatment target [1]. Weight outcomes in people who have both conditions are often harder to achieve, and the trial was designed around the gap the authors describe between the approved 2.4 mg dose and patients' weight goals [1].
One number patients may look for is missing. The published results compare 7.2 mg with placebo and do not report weight-loss figures for the 2.4 mg arm, so how much extra benefit 7.2 mg offers over the approved 2.4 mg dose cannot be judged from these results [1].
The 7.2 mg dose is not an approved product, and the trial did not test whether it reduces heart attacks, strokes or other long-term complications of diabetes; those outcomes were not part of this trial [1].
What happens next
The trial is registered as NCT05649137 and is now closed and completed [1]. It was funded by Novo Nordisk, which makes semaglutide [1]. Whether the company has applied for approval of a 7.2 mg dose, and on what timeline, has not been reported.
A correction to the published paper has appeared in the journal [1]. The correction notice does not describe what was changed.
Sources
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