MBX 2109, A Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-In-Human, Randomized Trial
An erratum to this article was published (J Clin Endocrinol Metab, 17 Mar 2025 ↗)
Authors' conclusion
The sustained-action PTH prodrug MBX 2109 was well tolerated with no unexpected, off-target safety issues. The long half-life and flat exposure profile of MBX 2109's biologically active PTH agonist supports once-weekly administration. MBX 2109 doses were identified for future studies.
Study context
- Population
- Healthy adults; mean age 43.3 years; 22.5% femalerandomized 4:1
- Participants
- 40 adults
- Comparison
- Once-weekly subcutaneous MBX 2109 vs placebo
- MBX 2109n = 32
- Placebon = 8reference
- Primary endpoint
- Safety and tolerability
Methodological detailsphase 1, first-in-human, double-blind, placebo-controlled, multiple ascending-dose
- Phase 1
- First-in-human
- Double-blind
- Placebo-controlled
- Multiple ascending-dose
Primary result
As reported in the abstract
TEAEs
MBX 2109
50% to 88%
Placebo
25%
Secondary outcomes
Pharmacokinetics (PK): half-lives
- Half-life of MBX 2109
- 79 to 95 hours
- Half-life of fatty-acylated biologically active parathyroid hormone (PTH) peptide
- 184 to 213 hours
- Active PTH peptide showed dose- and time-dependent exposure increases
Safety
| Outcome | MBX 2109 | Placebo |
|---|---|---|
| TEAEs | 50% to 88% | 25% |
- Treatment-emergent adverse events (TEAEs): range across MBX 2109 dose groups
TEAEs
- No severe or serious TEAEs observed with MBX 2109
- Injection-site reaction was the most common treatment-related TEAE
Original publication
MBX 2109, A Once-Weekly Parathyroid Hormone Replacement Therapy Prodrug: Phase 1, First-In-Human, Randomized Trial. J Clin Endocrinol Metab. Published 22 November 2024. doi:10.
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