Tirzepatide in Adults With Type 1 Diabetes: A Phase 2 Randomized Placebo-Controlled Clinical Trial.
Snaith JR, Frampton R, Samocha-Bonet D, Greenfield JR
Key Finding
In adults with type 1 diabetes and obesity, tirzepatide caused an average 10.3 kg (22.7 lb) weight loss over 12 weeks compared to just 0.7 kg in the placebo group - that's nearly 9% of their body weight lost.
What This Study Found
Statistics Decoded
Why This Matters
This opens a potential new treatment avenue for the estimated 40% of type 1 diabetics who struggle with obesity - a group that previously had limited safe weight loss options since most diabetes medications are designed for type 2. The dual benefit of weight loss plus reduced insulin needs could significantly lower cardiovascular risks in this vulnerable population.
Original Abstract
Overweight and obesity are prevalent in type 1 diabetes and contribute to cardiovascular risk. Tirzepatide, a gastric inhibitory polypeptide and glucagon-like peptide 1 receptor coagonist, has not been studied in type 1 diabetes. We conducted a 12-week, phase 2, double-blind, placebo-controlled trial in adults with type 1 diabetes and BMI >30 kg/m2. Participants were randomized to once-weekly subcutaneous tirzepatide (2.5 mg for 4 weeks, 5.0 mg for 8 weeks) or placebo. The primary end point was change in body weight at 12 weeks. Twenty-two of 24 adults with type 1 diabetes completed the study. After 12 weeks, the mean change in weight was -10.3 kg (95% CI -12.8 to -7.7 kg) in the tirzepatide group and -0.7 kg (95% CI -1.4 to 2.8 kg) in the placebo group, with an estimated treatment difference of -8.7 kg (95% CI -12.0 to -5.5 kg; P < 0.0001), representing 8.8% weight loss. In the tirzepatide group, 100% and 45% of participants experienced weight loss of ≥5% and ≥10% respectively, compared with 9% and 0% in the placebo group. Tirzepatide improved HbA1c (mean difference -0.4% [95% CI -0.7 to 0.0%] vs. placebo; P = 0.05) and reduced total daily insulin dose (-24.2 units/day tirzepatide and -0.3 units/day placebo; difference from baseline vs. placebo -35.1% [95% CI -46.5 to -21.3%; P = 0.0002]). There were no significant adverse events in either group. Among adults with type 1 diabetes and obesity, tirzepatide was superior to placebo for weight loss over 12 weeks.