HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial
Authors' conclusion
In this randomized clinical trial of adults with type 2 diabetes inadequately controlled with metformin, oral HRS-7535 improved glycemic control and was associated with modest weight reduction, with a safety profile consistent with that of GLP-1 RAs. Because HRS-7535 is a nonpeptide oral GLP-1 RA that does not require fasting administration or injection, it may be a viable treatment option, pending confirmation in phase 3 trials.
Study context
- Population
- Adults aged 18–75 years with T2D, hemoglobin A1c (HbA1c) 7.5%–11.0%, on stable metformin; 44 centers in China; mean age 52.3 years, 59.3% men, mean HbA1c 8.5%177 completed treatment
- Participants
- 194 adults
- Comparison
- Once-daily oral HRS-7535 vs placebo, add-on to metformin
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 16
Methodological detailsphase 2, double-blind, placebo-controlled, multicentre (44 centers in China), dose-escalation regimens for 60 and 90 mg, Enrolled May 10–December 18, 2023; analysed May 8–22, 2024
- Phase 2
- Double-blind
- Placebo-controlled
- Multicentre (44 centers in China)
- Dose-escalation regimens for 60 and 90 mg
- Enrolled May 10–December 18, 2023; analysed May 8–22, 2024
Primary result
As reported in the abstract
15 mg
−1.19
mean · 95% CI −1.54%–-0.84% · %
30 mg
−1.59
mean · 95% CI −1.94%–-1.24% · %
60 mg
−1.82
mean · 95% CI −2.16%–-1.48% · %
90 mg
−1.64
mean · 95% CI −1.97%–-1.30% · %
Placebo
−0.25
mean · 95% CI −0.60%–0.09% · %
- Placebo-adjusted differences ranged from −0.94% (95% CI, −1.43% to −0.45%) to −1.57% (95% CI, −2.05% to −1.08%)
- all P < .001
Secondary outcomes
| Outcome | Values |
|---|---|
| HbA1c <7.0% | Placebo 15.4% (95% CI 5.9%–30.5%) |
- Greater body weight reduction with 90 mg than placebo
HbA1c <7.0%
- HRS-7535 doses: proportions ranged from 48.7% (95% CI, 32.4%-65.2%) to 63.2% (95% CI, 46.0%-78.2%)
Safety
| Outcome | Values |
|---|---|
| AEs · 16 weeks | Placebo 71.8% |
- Adverse events (AEs) — AEs with HRS-7535 (range across doses)
- 28 of 39 (71.8%) to 33 of 39 (84.6%)
AEs · 16 weeks
- AEs were predominantly mild to moderate gastrointestinal events
Hypoglycemia and AEs of special interest
- Level 1 hypoglycemia, HRS-7535-treated patients
- 9 patients
- No level 2 or 3 hypoglycemia, pancreatitis, or ALT or AST elevations >3 times the upper limit of normal occurred
Original publication
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