Heart failure & cardiomyopathiesRandomised controlled trial
Novel Controlled Metabolic Accelerator for Obesity-Related Heart Failure with Preserved Ejection Fraction (HFpEF)
- Randomised controlled trial
- phase 2A
- double-blind
- placebo-controlled
- dose-escalation
- multicentre
Authors' conclusion
Among patients with obesity-related HFpEF, treatment with HU6 for 19 weeks led to modest but statistically significant weight loss without significant changes in peak VO2.
Study context
- Population
- Patients with chronic stable HFpEF and obesity56 completed
- Participants
- 66 patients
- Comparison
- HU6 vs placebo
- Primary endpoint
- Change in body weight
Primary result
Body weight
Between-group difference
−2.86 kg
95% CI −4.68 to −1.04
P = 0.003
HU6 vs Placebo
between-group difference −2.86 kg (95% CI −4.68 to −1.04); P = 0.003
As reported in the abstract
Further findings
| Outcome | between-group difference (kg) (95% CI) | P value | |
|---|---|---|---|
| Total fat mass | −2.96 (−4.50 to −1.42) | P < 0.001 | |
| −6−4−202Difference, kg (linear scale) |
| Outcome | between-group difference (%) (95% CI) | P value | |
|---|---|---|---|
| Percentage visceral fat | −1.3 (−2.1 to −0.5) | P = 0.003 | |
| −3−2−101Difference, % (linear scale) |
Muscle mass
- No significant loss of muscle mass
Peak VO2, 6-minute walk distance, KCCQ score, hs-CRP, NT-proBNP, diastolic function
- No statistically significant changes
Safety
events
| Outcome | HU6 | Placebo |
|---|---|---|
| Serious adverse events (all judged unrelated to treatment; including 1 death) | 4 | 1 |
- Serious adverse events (all judged unrelated to treatment; including 1 death): 5 participants in total
Original publication
Novel Controlled Metabolic Accelerator for Obesity-Related HFpEF. JAMA Cardiol. Published 1 June 2025. doi:10.1001/jamacardio.2025.0103
Summarised from the published abstract; every number is checked against it