Orforglipron ( LY3502970 ), a novel, oral non‐peptide glucagon‐like peptide‐1 receptor agonist: A Phase 1b, multicentre, blinded, placebo‐controlled, randomized, multiple‐ascending‐dose study in people with type 2 diabetes
Authors' conclusion
Orforglipron treatment resulted in meaningful reductions in HbA1c and body weight, with an adverse event profile consistent with that of other GLP-1RAs. Orforglipron may provide a safe and effective once-daily oral treatment alternative to injectable GLP-1RAs or peptide oral formulations without water and food restrictions.
Study context
- Population
- Adults aged 18 to 70 years with T2D and HbA1c ≥53.0 mmol/mol (7.0%) and ≤91.3 mmol/mol (10.5%)
- Participants
- 51 vs 17
- Comparison
- Daily oral orforglipron vs placebo for 12 weeks
- Orforglipronn = 51
- Placebon = 17reference
- Primary endpoint
- Safety, pharmacokinetics and pharmacodynamics
Methodological detailsPhase 1b, multiple-ascending-dose, double-blind, placebo-controlled, multicentre, randomized 3:1, First group established that weekly dose escalation was generally well tolerated, enabling parallel-arm design for the following four groups
- Phase 1b
- Multiple-ascending-dose
- Double-blind
- Placebo-controlled
- Multicentre
- Randomized 3:1
- First group established that weekly dose escalation was generally well tolerated, enabling parallel-arm design for the following four groups
Primary result
As reported in the abstract
HbA1c change · Week 12
Orforglipron
−1.5% to −1.8%
mean
Placebo
−0.4%
mean
Further findings
Baseline HbA1c and body weight
Body weight Orforglipron 88.4 kg · Placebo 90.3 kg
| Outcome | Orforglipron | Placebo |
|---|---|---|
| Body weight change · Week 12Range across orforglipron doses | −0.24 to −5.8 kg | 0.5 kg |
Pharmacokinetics: t1/2 · Week 12
- Mean t1/2 range
- 29 to 49 hours
Safety
Adverse events
- Most common AEs were gastrointestinal-related and occurred early in treatment, similar to other GLP-1 RAs
Original publication
Orforglipron ( LY3502970 ), a novel, oral non‐peptide glucagon‐like peptide‐1 receptor agonist: A Phase 1b, multicentre, blinded, placebo‐controlled, randomized, multiple‐ascending‐dose study in people with type 2 diabetes. Diabetes Obes Metab. Published 1 June 2023. doi:10.
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