Once‐daily oral small‐molecule glucagon‐like peptide‐1 receptor agonist lotiglipron (PF‐07081532) for type 2 diabetes and obesity: Two randomized, placebo‐controlled, multiple‐ascending‐dose Phase 1 studies
Authors' conclusion
The profile of once-daily lotiglipron with doses up to 180 mg, as observed in these two Phase 1 studies, indicated a safety and tolerability profile consistent with the mechanism of action, with dose-dependent reductions in glycaemic indices (T2D) and body weight (both populations) after multiple doses.
Study context
- Population
- Participants with T2D (treated 28 or 42 days) and/or obesity without diabetes (treated 42 days)74 T2D, 26 obesity
- Comparison
- Once-daily oral lotiglipron vs placebo
- Primary endpoint
- Safety, tolerability, pharmacokinetics and pharmacodynamics
Methodological detailstwo Phase 1 studies, double-blind, placebo-controlled, multiple-ascending-dose
- Two Phase 1 studies
- Double-blind
- Placebo-controlled
- Multiple-ascending-dose
Primary result
As reported in the abstract
Most adverse events were mild
89.6%
Further findings
| Outcome | Lotiglipron | Placebo |
|---|---|---|
| Change from baseline in HbA1c (T2D, 180-mg dose) · 42 daysLeast squares mean, % | −1.61 (90% CI −2.08–-1.14) | −0.61 (90% CI −1.56–0.34) |
| Change from baseline in body weight (T2D, 180-mg dose) · 42 daysLeast squares mean, kg | −5.10 (90% CI −6.62–-3.58) | −2.06 (90% CI −4.47–0.36) |
- Change from baseline in HbA1c (T2D, 180-mg dose): 180-mg dose
- Change from baseline in body weight (T2D, 180-mg dose): 180-mg dose
Change from baseline in body weight (T2D, 180-mg dose) · 42 days
- Similar magnitude of weight loss in participants with obesity
Safety
- Most adverse events were mild
- 89.6%
- Nausea the most frequently reported in both studies
- No clinically meaningful adverse trends in safety laboratory tests, vital signs or ECG parameters
Original publication
Once‐daily oral small‐molecule glucagon‐like peptide‐1 receptor agonist lotiglipron (PF‐07081532) for type 2 diabetes and obesity: Two randomized, placebo‐controlled, multiple‐ascending‐dose Phase 1 studies. Diabetes Obes Metab. Published 16 May 2024. doi:10.
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