Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial
Authors' conclusion
In people with type 2 diabetes, treatment with CagriSema resulted in clinically relevant improvements in glycaemic control (including CGM parameters). The mean change in HbA1c with CagriSema was greater versus cagrilintide, but not versus semaglutide. Treatment with CagriSema resulted in significantly greater weight loss versus semaglutide and cagrilintide and was well tolerated. These data support further investigation of CagriSema in this population in longer and larger phase 3 studies.
Study context
- Population
- Adults with T2D and BMI ≥27 kg/m² on metformin with or without an SGLT2i, 17 sites in the USA; mean age 58 years, 64% malerandomised 1:1:1
- Participants
- 92 adults
- Comparison
- Once-weekly CagriSema vs semaglutide vs cagrilintide
- CagriSeman = 31
- Semaglutiden = 31reference
- Cagrilintiden = 30reference
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- Week 32
Methodological detailsmulticentre, double-blind, active-controlled, phase 2, Central randomisation via interactive web response system, stratified by SGLT2i use
- Multicentre
- Double-blind
- Active-controlled
- Phase 2
- Central randomisation via interactive web response system, stratified by SGLT2i use
Primary result
As reported in the abstract
CagriSema
−2.2
mean · SE 0.15 · percentage points
Semaglutide
−1.8
mean · SE 0.16 · percentage points
Cagrilintide
−0.9
mean · SE 0.15 · percentage points
Secondary outcomes
TIR (3.9-10.0 mmol/L) · week 32
Baseline
| Outcome | CagriSema | Semaglutide | Cagrilintide | P value |
|---|---|---|---|---|
| Mean change in bodyweight · baseline to week 32CagriSema vs Semaglutide · greater with CagriSema · % | −15.6 (SE 1.26) | −5.1 (SE 1.26) | −8.1 (SE 1.23) | P < 0.0001 |
| Mean change in bodyweight · baseline to week 32CagriSema vs Cagrilintide · greater with CagriSema | P < 0.0001 | |||
| Mean change in FPG · baseline to week 32CagriSema vs Cagrilintide · greater with CagriSema · mmol/L | −3.3 (SE 0.3) | −2.5 (SE 0.4) | −1.7 (SE 0.3) | P = 0.0010 |
| Mean change in FPG · baseline to week 32CagriSema vs Semaglutide | P = 0.10 |
Safety
Adverse events
- Adverse events — Level 2 or 3 hypoglycaemia
- 0
- Adverse events — Fatal adverse events
- 0
- Adverse events: safety analyses in randomised participants who received ≥1 dose
Adverse events
- Mild or moderate gastrointestinal adverse events were most common
Original publication
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