Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial
Authors' conclusion
In this 72-week trial in adults living with obesity and type 2 diabetes, once-weekly tirzepatide 10 mg and 15 mg provided substantial and clinically meaningful reduction in bodyweight, with a safety profile that was similar to other incretin-based therapies for weight management.
Study context
- Population
- Adults (≥18 years) with obesity and T2D: Body-mass index (BMI) ≥27 kg/m² and HbA1c 7–10% (53–86 mmol/mol); mean age 54.2 years, 51% female; baseline mean bodyweight 100.7 kg, BMI 36.1 kg/m², HbA1c 8.02%randomized 1:1:1
- Participants
- 938 adults
- Comparison
- Once-weekly subcutaneous tirzepatide 10 mg or 15 mg vs placebo
- Tirzepatide 10 mgn = 312
- Tirzepatide 15 mgn = 311
- Placebon = 315reference
- Primary endpoint
- Coprimary: percent change in bodyweight from baseline and bodyweight reduction ≥5%
- Follow-up
- 72 weeks
Methodological detailsphase 3, double-blind, placebo-controlled, multicentre, seven countries
- Phase 3
- Double-blind
- Placebo-controlled
- Multicentre
- Seven countries
Primary result
As reported in the abstract
Least-squares mean change in bodyweight · week 72
Tirzepatide 10 mg
−12.8
least-squares mean · SE 0.6 · %
Tirzepatide 15 mg
−14.7
least-squares mean · SE 0.5 · %
Placebo
−3.2
least-squares mean · SE 0.5 · %
Each group vs placeboEstimated treatment difference, percentage points (95% CI)P value
Tirzepatide 10 mg
−9.6(−11.1 to −8.1)
P < 0.0001Tirzepatide 15 mg
−11.6(−13.0 to −10.1)
P < 0.0001Safety
Adverse events
- AEs leading to treatment discontinuation
- <5%
- Serious AEs, participants overall
- 68 (7%)
- Deaths in tirzepatide 10 mg group, not considered treatment-related by investigator
- 2
- Most frequent AEs with tirzepatide gastrointestinal (nausea, diarrhoea, vomiting), mostly mild to moderate
Original publication
Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. Published 26 June 2023. doi:10.
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