Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial
Authors' conclusion
In adults with type 2 diabetes, retatrutide significantly improved total body fat mass reduction compared with placebo and dulaglutide. The proportion of lean mass loss to weight loss was similar to other obesity treatments. These findings could provide reassurance that a greater proportion of lean mass is not lost with retatrutide despite the overall increased weight loss.
Study context
- Population
- Adults aged 18–75 years with T2D, HbA1c 7.0–10.5%, stable bodyweight and BMI 25–50 kg/m²103 completed with both DXA scans
- Participants
- 189 adults
- Comparison
- Retatrutide vs placebo and dulaglutide 1.5 mg
- Retatrutide 0.5 mgn = 32
- Retatrutide 4 mg (pooled)n = 31
- Retatrutide 8 mg (pooled)n = 33
- Retatrutide 12 mgn = 30
- Dulaglutide 1.5 mgn = 34
- Placebon = 29reference
- Primary endpoint
- Percent change from baseline in total fat mass by DXA
- Follow-up
- Week 36
Methodological detailsdouble-blind, parallel-group, placebo-controlled, 42 medical centres in the USA
- Double-blind
- Parallel-group
- Placebo-controlled
- 42 medical centres in the USA
Primary result
As reported in the abstract
Percent reduction from baseline in total fat mass
Each group vs placeboLeast squares mean change difference (95% CI)P value
Retatrutide 0.5 mg
−0.4(−4.0 to 3.2)
P = 0.83Retatrutide 4 mg (pooled)
−10.7(−17.2 to −4.2)
P = 0.0013Retatrutide 8 mg (pooled)
−21.6(−27.1 to −16.1)
P < 0.0001Retatrutide 12 mg
−18.7(−25.1 to −12.3)
P < 0.0001Safety
| Outcome | Values |
|---|---|
| Serious adverse events | Placebo 7% · Retatrutide 0.5 mg 6% · Retatrutide 4 mg (pooled) 0 events · Retatrutide 8 mg (pooled) 9% · Retatrutide 12 mg 3% · Dulaglutide 1.5 mg 0 events |
- Serious adverse events — Deaths
- 0
Serious adverse events
- Adverse events similar between groups; gastrointestinal events most frequent
Original publication
Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial. Lancet Diabetes Endocrinol. Published 30 June 2025. doi:10.
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