Oral HRS-7535 Lowered A1c in Trial - Report - MDSpire

Oral HRS-7535 Lowered A1c in Trial

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  • Kathryn Wighton

  • June 5, 2026

  • 9 min

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Clinical Report: Oral HRS-7535 Lowered A1c in Trial

Overview

Expand on the safety profile to include specific adverse events or tolerability.

Background

Type 2 diabetes management often requires effective glycemic control to prevent complications. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have emerged as a key treatment option, but adherence can be challenging due to administration requirements. HRS-7535, a nonpeptide oral GLP-1 RA, offers a promising alternative that does not necessitate fasting, potentially improving patient compliance.

Data Highlights

Dose (mg)Mean A1c Reduction (%)Placebo-Adjusted Reduction (%)% Achieving A1c < 7.0%
151.190.9449
301.591.3463
601.821.5763
901.641.3960
Placebo0.25-15

Key Findings

  • HRS-7535 reduced hemoglobin A1c by up to 1.82 percentage points compared to placebo.
  • 49% to 63% of patients on HRS-7535 achieved A1c levels below 7.0% versus 15% on placebo.
  • Rescue antihyperglycemic therapy was required in only 3% to 8% of patients receiving HRS-7535, compared to 31% in the placebo group.
  • Weight reduction was modest, with a maximum of 2.63% in the 90 mg group compared to placebo.
  • Changes in fasting plasma glucose and postprandial glucose were significantly greater with HRS-7535 than with placebo.
  • The 60 mg dose provided similar efficacy to the 90 mg dose, suggesting potential for dose optimization.

Clinical Implications

The findings suggest that HRS-7535 may be an effective oral treatment option for patients with type 2 diabetes inadequately controlled on metformin. Its non-fasting requirement could enhance adherence, making it a valuable addition to diabetes management strategies.

Conclusion

HRS-7535 demonstrates significant efficacy in lowering A1c levels in type 2 diabetes patients, warranting further investigation in larger trials to confirm its safety and optimal dosing.

Related Resources & Content

  1. JAMA Network Open, 2023 -- HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial
  2. The Journal of Clinical Endocrinology & Metabolism — Comparative Analysis of Once-Weekly Insulin Icodec and Daily Insulin Regimens: Efficacy and Hypoglycemia Outcomes Across Demographic Groups
  3. Clinical Research in Cardiology — Update on Clinical Trials and Registries Discussed at the 2010 American College of Cardiology Congress: Insights from ACCORD, INVEST, NAVIGATOR, RACE II, SORT OUT III, CSP-474, DOSE, ASPIRE, and Others
  4. Drugs - Real World Outcomes — Impact of Gliclazide Alone or in Combination with Metformin on Glycemic Management in Indian Patients with Type 2 Diabetes Mellitus: A Retrospective, Longitudinal Analysis Utilizing Electronic Medical Records
  5. ADA Standards of Care in Diabetes—2026
  6. HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial | Diabetes and Endocrinology | JAMA Network Open | JAMA Network

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