SURMOUNT-2 RCT Results: Does Tirzepatide Treatment Improve Weight Loss for Individuals with Obesity and Type 2 Diabetes?
BACKGROUND AND PURPOSE:
- Tirzepatide is a once-weekly injectable insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist
- Demonstrated weight loss in non-diabetic patients (SURMOUNT-1)
- Garvey et al. (The Lancet, 2023) assessed the efficacy and safety of tirzepatide for weight management in people with obesity and type 2 diabetes
METHODS:
- Phase 3, double-blind, randomized, placebo-controlled trial
- SURMOUNT-2 trial, 7 countries
- Participants
- BMI ≥27 kg/m2
- Glycated hemoglobin (HbA1c) 7 to 10% (53 to 86 mmol/mol)
- Interventions
- Once-weekly, subcutaneous tirzepatide (10 mg or 15 mg) for 72 weeks
- Placebo
- Study design
- Intention-to-treat
- Primary outcomes
- The percent change in bodyweight from baseline
- Bodyweight reduction of 5% or higher
RESULTS:
- Tirzepatide 10 mg: 312 participants | Tirzepatide 15 mg: 311 | Placebo: 315
- Mean age: 54.2 (SD, 10.6) years | Female: 51%
- White: 76% | Hispanic/Latino: 60%
- Baseline characteristics
- Mean bodyweight: 100.7 (SD, 21.1) kg
- BMI: 36.1 (SD, 6.6) kg/m2
- HbA1c: 8.02% (SD, 0.89) | 64.1 (SD, 9.7) mmol/mol
- Least-squares mean change in bodyweight at week 72
- Tirzepatide 10 mg: –12.8%
- Tirzepatide 15 mg: –14.7%
- Placebo: –3.2%
- There was a significant reduction in body weight over 72 weeks with tirzepatide (P<0.0001)
- Tirzepatide 10 mg vs placebo: –9.6% percentage points (95% CI, –11.1 to –8.1)
- Tirzepatide 15 mg vs placebo: –11.6% percentage points (95% CI, –13.0 to –10.1)
- More participants treated with tirzepatide vs placebo met bodyweight reduction thresholds of 5% or higher
- Tirzepatide 10 mg: 79%
- Tirzepatide 15 mg: 83%
- Placebo: 32%
- Mean HbA1c improved with tirzepatide vs placebo over 72 weeks
- Tirzepatide 10 mg: 6.0%
- Tirzepatide 15 mg: 5.9%
- Placebo: 7.5%
- The most frequent adverse events with tirzepatide were
- Nausea | Diarrhea | Vomiting
- Most adverse events were mild to moderate, and few events led to treatment discontinuation (<5%)
- Serious adverse events: 7% of participants
- There were 2 deaths in the tirzepatide 10 mg group
- Neither related to study treatment
CONCLUSION:
- For adults with obesity and type 2 diabetes, tirzepatide 10 mg or 15 mg for 72 weeks provided statistically and clinically significant weight reduction compared to placebo
- The authors state
In conclusion, in adults with a BMI of 27 kg/m2 or higher and type 2 diabetes, once-weekly treatment with tirzepatide demonstrated substantial, clinically meaningful bodyweight reductions of up to 15%, with weight reductions of 20% or higher reached by up to nearly one-third of tirzepatide-treated participants
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