Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of the novel long‐acting glucagon analogue HM15136 in overweight and obese patients with co‐morbidities
Authors' conclusion
This study of HM15136 provides a preliminary safety and tolerability profile with initial insights into its efficacy profile.
Study context
- Population
- Overweight/obese patients with dyslipidaemia and/or hypertension; part 1 without T2D, part 2 with T2D
- Comparison
- Once-weekly subcutaneous HM15136 vs placebo for 12 weeks
- Primary endpoint
- Safety, tolerability, pharmacokinetics and pharmacodynamics
- Follow-up
- 12-week treatment period
Methodological detailsphase 1, double-blind, placebo-controlled, two-part, multiple ascending doses
- Phase 1
- Double-blind
- Placebo-controlled
- Two-part
- Multiple ascending doses
Primary result
As reported in the abstract
TEAE, part 1
Further findings
TEAE, part 2 (T2D)
- Treatment-emergent adverse event (TEAE), part 2 (T2D): HM15136 n=12; placebo n=4
Weight reduction, part 1
- Dose-dependent weight reduction at 0.02/0.04/0.06 mg/kg
- 0.5%/2.3%/2.6%
- Dose-dependent increases in mean HM15136 serum concentration and fasting plasma glucose (FPG)
Weight reduction, part 2
- Weight reduction with 0.02 mg/kg
- 0.9%
- Dose-dependent increases in mean HM15136 serum concentration
Safety
Anti-HM15136 antibodies
- Part 1, HM15136
- 5/27 (18.5%)
- Part 2
- 2 (16.7%)
FPG >200 mg/dL, part 2
- 0.02 mg/kg
- 4/9 (44.4%)
- 0.06 mg/kg
- 2/3 (66.7%)
- 0.06 mg/kg not tolerated in part 2 due to hyperglycaemia
Serious TEAEs leading to discontinuation
- No serious TEAEs leading to discontinuation in either part
Original publication
Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of the novel long‐acting glucagon analogue HM15136 in overweight and obese patients with co‐morbidities. Diabetes Obes Metab. Published 13 June 2023. doi:10.
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