---
title: "Safiglipron: once-daily oral GLP-1 receptor agonist shows significant HbA1c reductions in early ty"
id: "nature-1-oral-small-molecule-glp-1-receptor-agonist-safiglipron-in-early-type-2-diabetes"
canonical_url: "https://medichelpline.com/clinical-feed/nature-1-oral-small-molecule-glp-1-receptor-agonist-safiglipron-in-early-type-2-diabetes"
content_type: "clinical_feed_article"
specialty: "Endocrinology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04651-9"
published_at: "2026-09-29T10:14:26.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Safiglipron: once-daily oral GLP-1 receptor agonist shows significant HbA1c reductions in early ty
## Provenance & Clinical Metadata
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- **Specialty:** [Endocrinology](https://medichelpline.com/clinical-feed/endocrinology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04651-9)
- **Published At:** 2026-09-29T10:14:26.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- OUTSTAND-1 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in China testing once-daily oral **safiglipron**, a small-molecule **GLP-1 receptor agonist**, as monotherapy in adults with early type 2 diabetes managed with diet and exercise alone. - 284 participants (mean baseline **HbA1c** 7.95%, median diabetes duration 1.6 years, 33.1% women) were randomized to safiglipron 30 mg (n=70), 60 mg (n=70), 90 mg (n=72) or placebo (n=72) for a 32-week placebo-controlled core period followed by a 20-week active-treatment extension. - Primary outcome: placebo-adjusted HbA1c reductions at week 32 were −1.22% (30 mg), −1.20% (60 mg) and −1.45% (90 mg); all comparisons were statistically significant (P < 0.0001) using the treatment policy estimand. - Large proportions of participants on safiglipron achieved glycemic targets compared with placebo: HbA1c <7.0% in 71.4–77.8% versus 25.0%; HbA1c ≤6.5% in 58.6–68.1% versus 16.7% (reported ranges correspond to the three doses). - Placebo-adjusted fasting plasma glucose reductions were −1.58, −1.68 and −2.08 mmol L−1 for 30 mg, 60 mg and 90 mg respectively (all P < 0.0001). - Body weight reductions were modest and dose-related versus placebo: −0.65% (30 mg), −2.23% (60 mg) and −3.56% (90 mg). - Other secondary outcomes favoured **safiglipron**, including attainment of HbA1c <5.7%, improvements in postprandial glycaemia, HOMA-β, HOMA-IR, disposition index and reduced waist circumference; insulin and C-peptide responses varied by dose. Changes in treatment satisfaction were limited. - Gastrointestinal adverse events were the most common safety signal and were mostly mild or moderate. Treatment discontinuation due to adverse events occurred in 1.4% (30 mg), 2.9% (60 mg), 6.9% (90 mg) and 0% (placebo). - Trial enrolled 475 screened, 375 entered single-blind run-in, 284 randomized across 46 sites in China between 21 October 2024 and 31 March 2025; 243 (85.6%) completed 52-week treatment and 261 (91.9%) completed follow-up. - The authors conclude once-daily oral **safiglipron** is an effective treatment option for type 2 diabetes based on robust HbA1c lowering and an acceptable safety profile in this population.
## Clinical Analysis & Structured Key Points
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[articles](https://www.nature.com/nm/articles?type=article) 4. article Oral small-molecule GLP-1 receptor agonist safiglipron in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial [ Download PDF ](https://www.nature.com/articles/s41591-026-04651-9.pdf) [ Download PDF ](https://www.nature.com/articles/s41591-026-04651-9.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 29 September 2026 # Oral small-molecule GLP-1 receptor agonist safiglipron in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial * [Miao Yu (于淼)](https://www.nature.com/articles/s41591-026-04651-9#auth-Miao-Yu-Aff1)[1](https://www.nature.com/articles/s41591-026-04651-9#Aff1) [na1](https://www.nature.com/articles/s41591-026-04651-9#na1), * [Liang Peng (彭亮)](https://www.nature.com/articles/s41591-026-04651-9#auth-Liang-Peng-Aff2) [ORCID: orcid.org/0000-0002-5407-3737](https://orcid.org/0000-0002-5407-3737)[2](https://www.nature.com/articles/s41591-026-04651-9#Aff2) [na1](https://www.nature.com/articles/s41591-026-04651-9#na1), * [Chengyan Jiang (蒋成燕)](https://www.nature.com/articles/s41591-026-04651-9#auth-Chengyan-Jiang-Aff3)[3](https://www.nature.com/articles/s41591-026-04651-9#Aff3), * [Xianghua Zhang (张响华)](https://www.nature.com/articles/s41591-026-04651-9#auth-Xianghua-Zhang-Aff4)[4](https://www.nature.com/articles/s41591-026-04651-9#Aff4), * [Qifu Li (李启富)](https://www.nature.com/articles/s41591-026-04651-9#auth-Qifu-Li-Aff5) [ORCID: orcid.org/0000-0001-7249-6445](https://orcid.org/0000-0001-7249-6445)[5](https://www.nature.com/articles/s41591-026-04651-9#Aff5), * [Lihui Zhang (张力辉)](https://www.nature.com/articles/s41591-026-04651-9#auth-Lihui-Zhang-Aff6)[6](https://www.nature.com/articles/s41591-026-04651-9#Aff6), * [Xiuhai Su (苏秀海)](https://www.nature.com/articles/s41591-026-04651-9#auth-Xiuhai-Su-Aff7)[7](https://www.nature.com/articles/s41591-026-04651-9#Aff7), * [Zhaoyang Zeng (曾朝阳)](https://www.nature.com/articles/s41591-026-04651-9#auth-Zhaoyang-Zeng-Aff8)[8](https://www.nature.com/articles/s41591-026-04651-9#Aff8), * [Shuang Yan (闫爽)](https://www.nature.com/articles/s41591-026-04651-9#auth-Shuang-Yan-Aff9)[9](https://www.nature.com/articles/s41591-026-04651-9#Aff9), * [Jinyang Wang (王金羊)](https://www.nature.com/articles/s41591-026-04651-9#auth-Jinyang-Wang-Aff10)[10](https://www.nature.com/articles/s41591-026-04651-9#Aff10), * [Debin Huang (黄德斌)](https://www.nature.com/articles/s41591-026-04651-9#auth-Debin-Huang-Aff11)[11](https://www.nature.com/articles/s41591-026-04651-9#Aff11), * [Sihong Wang (王思宏)](https://www.nature.com/articles/s41591-026-04651-9#auth-Sihong-Wang-Aff12)[12](https://www.nature.com/articles/s41591-026-04651-9#Aff12), * [Na Liu (刘纳)](https://www.nature.com/articles/s41591-026-04651-9#auth-Na-Liu-Aff13)[13](https://www.nature.com/articles/s41591-026-04651-9#Aff13), * [Yimei Xu (徐奕玫)](https://www.nature.com/articles/s41591-026-04651-9#auth-Yimei-Xu-Aff2)[2](https://www.nature.com/articles/s41591-026-04651-9#Aff2), * [Guo Tang (唐果)](https://www.nature.com/articles/s41591-026-04651-9#auth-Guo-Tang-Aff2) [ORCID: orcid.org/0000-0001-5411-1441](https://orcid.org/0000-0001-5411-1441)[2](https://www.nature.com/articles/s41591-026-04651-9#Aff2), * [Fangli Dong (董方丽)](https://www.nature.com/articles/s41591-026-04651-9#auth-Fangli-Dong-Aff2)[2](https://www.nature.com/articles/s41591-026-04651-9#Aff2), * [Yanlin Ma (马妍霖)](https://www.nature.com/articles/s41591-026-04651-9#auth-Yanlin-Ma-Aff2)[2](https://www.nature.com/articles/s41591-026-04651-9#Aff2), * [Zi Ye (叶子)](https://www.nature.com/articles/s41591-026-04651-9#auth-Zi-Ye-Aff2) [ORCID: orcid.org/0009-0001-7740-1238](https://orcid.org/0009-0001-7740-1238)[2](https://www.nature.com/articles/s41591-026-04651-9#Aff2) & * [Xinhua Xiao (肖新华)](https://www.nature.com/articles/s41591-026-04651-9#auth-Xinhua-Xiao-Aff1) [ORCID: orcid.org/0000-0001-5441-7766](https://orcid.org/0000-0001-5441-7766)[1](https://www.nature.com/articles/s41591-026-04651-9#Aff1) * [on behalf of the OUTSTAND-1 Investigator Group](https://www.nature.com/articles/s41591-026-04651-9#group-1) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04651-9#citeas) [ Save article ](https://www.nature.com/articles/s41591-026-04651-9/save-research?_csrf=M5TzjSANXOmYiEzPvP5Rh7VpdZ1I-Gvn) [ View saved research ](https://www.nature.com/saved-research) ## Abstract Safiglipron is an oral small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist administered without fasting or dietary restrictions. We evaluated its efficacy and safety in OUTSTAND-1, a phase 3, multicenter, randomized, double-blind, placebo-controlled trial at 46 sites in China. We randomized 284 adults with type 2 diabetes managed with diet and exercise alone (mean baseline HbA1c 7.95%, median diabetes duration 1.6 years, 33.1% women) to once-daily safiglipron 30 mg (_n_ = 70), 60 mg (_n_ = 70), 90 mg (_n_ = 72) or placebo (_n_ = 72) for 32 weeks, followed by a 20-week active-treatment extension. For the primary endpoint, placebo-adjusted treatment differences in HbA1c change from baseline to week 32 were −1.22% (95% CI, −1.53 to −0.91), −1.20% (95% CI, −1.52 to −0.89) and −1.45% (95% CI, −1.75 to −1.14) for 30 mg, 60 mg and 90 mg, respectively (all _P_ < 0.0001; treatment policy estimand). Secondary outcomes showed HbA1c < 7.0% in 71.4−77.8% versus 25.0%, HbA1c ≤ 6.5% in 58.6−68.1% versus 16.7% and placebo-adjusted fasting plasma glucose differences of −1.58, −1.68 and −2.08 mmol l−1, respectively (all _P_ < 0.0001). Body weight differences were modest (−0.65%, −2.23% and −3.56% versus placebo). Other secondary outcomes generally favored safiglipron for HbA1c < 5.7% attainment, postprandial glycemia, homeostatic model assessment of β cell function (HOMA-β), homeostatic model assessment of insulin resistance (HOMA-IR), disposition index and waist circumference, with less rescue therapy use. Insulin and C-peptide responses varied by dose, and changes in treatment satisfaction were limited. Gastrointestinal adverse events were most common and mostly mild or moderate. Adverse events led to treatment discontinuation in 1.4%, 2.9%, 6.9% and 0% of participants receiving safiglipron 30 mg, 60 mg, 90 mg and placebo, respectively. These findings support once-daily oral safiglipron as an effective treatment option for type 2 diabetes. ClinicalTrials.gov identifier: [NCT06672172](http://clinicaltrials.gov/study/NCT06672172). ### Explore related subjects Discover the latest articles and news in related subjects. * [Phase III trials](https://www.nature.com/subjects/phase-iii-trials) * [Type 2 diabetes](https://www.nature.com/subjects/type-2-diabetes-mellitus) * [Incretin-Based Therapeutics for Type 2 Diabetes Management](https://www.nature.com/subjects/incretin-based-therapeutics-for-type-2-diabetes-management) ## Main Diabetes affects an estimated 589 million adults worldwide, more than 90% of whom have type 2 diabetes[1](https://www.nature.com/articles/s41591-026-04651-9#ref-CR1 "Genitsaridi, I. et al. 11th edition of the IDF Diabetes Atlas: global, regional, and national diabetes prevalence estimates for 2024 and projections for 2050. Lancet Diabetes Endocrinol. 14, 149–156 \(2026\)."). β cell dysfunction and insulin resistance drive progressive loss of glycemic control, underscoring the importance of effective treatment early in the disease course[2](https://www.nature.com/articles/s41591-026-04651-9#ref-CR2 "Yau, B., Ghislain, J., Kebede, M. A., Hughes, J. & Poitout, V. The role of the beta cell in type 2 diabetes: new findings from the last 5 years. Diabetologia 68, 2092–2103 \(2025\)."). GLP-1 receptor agonists provide effective glucose lowering and weight reduction, with cardiorenal benefits established across multiple large outcome trials[3](https://www.nature.com/articles/s41591-026-04651-9#ref-CR3 "Badve, S. V. et al. Effects of GLP-1 receptor agonists on kidney and cardiovascular disease outcomes: a meta-analysis of randomised controlled trials. Lancet Diabetes Endocrinol. 13, 15–28 \(2025\)."). Current guidelines recommend their use regardless of metformin in people with established or high-risk cardiovascular disease or chronic kidney disease, reflecting the expanding role of this class beyond conventional stepwise glucose-lowering intensification[4](https://www.nature.com/articles/s41591-026-04651-9#ref-CR4 "American Diabetes Association Professional Practice Committee for Diabetes. 9. Pharmacologic approaches to glycemic treatment: standards of care in diabetes—2026. Diabetes Care 49, S183–S215 \(2026\)."). Despite these benefits, most approved GLP-1 receptor agonists require subcutaneous injection, which can represent a practical barrier for some patients[5](https://www.nature.com/articles/s41591-026-04651-9#ref-CR5 "Boye, K., Ross, M., Mody, R., Konig, M. & Gelhorn, H. Patients’ preferences for once-daily oral versus once-weekly injectable diabetes medications: the REVISE study. Diabetes Obes. Metab. 23, 508–519 \(2021\)."). Oral semaglutide partly addressed this barrier but, as a peptide-based formulation, requires fasting administration with restricted fluid intake[6](https://www.nature.com/articles/s41591-026-04651-9#ref-CR6 "Aroda, V. R. et al. PIONEER 1: randomized clinical trial of the efficacy and safety of oral semaglutide monotherapy in comparison with placebo in patients with type 2 diabetes. Diabetes Care 42, 1724–1732 \(2019\)."),[7](https://www.nature.com/articles/s41591-026-04651-9#ref-CR7 "Wang, W. et al. Efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes \(PIONEER 11\): a double-blind, phase IIIa, randomised trial. Diabetologia 67, 1783–1799 \(2024\)."). Oral non-peptide small-molecule GLP-1 receptor agonists may avoid these peptide-related dosing constraints. Orforglipron has demonstrated glycemic and weight benefits across phase 3 trials in diverse clinical settings[8](https://www.nature.com/articles/s41591-026-04651-9#ref-CR8 "Rosenstock, J. et al. Orforglipron, an oral small-molecule GLP-1 receptor agonist, in early type 2 diabetes. N. Engl. J. Med. 393, 1065–1076 \(2025\)."),[9](https://www.nature.com/articles/s41591-026-04651-9#ref-CR9 "Welch, M. et al. Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin \(ACHIEVE-2\): a multicentre, randomised, non-inferiority, open-label, phase 3 trial. Lancet 408, 125–140 \(2026\)."),[10](https://www.nature.com/articles/s41591-026-04651-9#ref-CR10 "Rosenstock, J. et al. Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes \(ACHIEVE-3\): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial. Lancet 407, 1147–1160 \(2026\)."),[11](https://www.nature.com/articles/s41591-026-04651-9#ref-CR11 "Giorgino, F. et al. Orforglipron added to titrated insulin glargine in type 2 diabetes: the ACHIEVE-5 randomized clinical trial. JAMA 336, 389–399 https://doi.org/10.1001/jama.2026.9512 \(2026\)."). Safiglipron (proposed International Nonproprietary Name (INN)[12](https://www.nature.com/articles/s41591-026-04651-9#ref-CR12 "INN Proposed List 134 https://www.who.int/publications/m/item/inn-pl-134 \(World Health Organization, 2026\)."), HRS-7535) is a structurally distinct, once-daily oral small-molecule GLP-1 receptor agonist. Across three phase 2 proof-of-concept and dose-finding trials, safiglipron reduced HbA1c in patients with type 2 diabetes inadequately controlled with metformin[13](https://www.nature.com/articles/s41591-026-04651-9#ref-CR13 "Guo, L. et al. HRS-7535 for type 2 diabetes inadequately controlled with metformin: a randomized clinical trial. JAMA Netw. Open 9, e2615622 \(2026\)."), body weight in adults with obesity[14](https://www.nature.com/articles/s41591-026-04651-9#ref-CR14 "Gu, W. et al. HRS-7535, an oral small-molecule GLP-1 receptor agonist, in Chinese adults with obesity without diabetes: a randomized, double-blind, placebo-controlled phase 2 trial. Nat. Commun. 17, 7867 https://doi.org/10.1038/s41467-026-73018-y \(2026\).") and albuminuria in patients with diabetic kidney disease[15](https://www.nature.com/articles/s41591-026-04651-9#ref-CR15 "Lv, R. et al. Efficacy and safety of HRS-7535, an oral small-molecule GLP-1 receptor agonist, in patients with diabetic kidney disease \(SOLID-DKD\): a randomised, double-blind, placebo-controlled, phase 2 trial. EClinicalMedicine 97, 104045 \(2026\)."). On the basis of these phase 2 findings, three safiglipron doses were advanced into the phase 3 OUTSTAND clinical development program. We conducted the OUTSTAND-1 trial to assess the efficacy and safety of safiglipron as monotherapy in Chinese adults with type 2 diabetes managed with diet and exercise alone. ## Results ### Trial design and participants OUTSTAND-1 was a multicenter, randomized, double-blind, placebo-controlled trial evaluating once-daily oral safiglipron (30 mg, 60 mg and 90 mg, with dose titration in 30-mg increments every 4 weeks) versus placebo in adults aged 18−75 years with type 2 diabetes (HbA1c 7.0−10.0%, body mass index (BMI) 19.0−40.0 kg m−2) managed with diet and exercise without glucose-lowering medication for at least 2 months. The trial comprised a 32-week placebo-controlled core period followed by a 20-week extension period (Extended Data Fig. [1](https://www.nature.com/articles/s41591-026-04651-9#Fig4)). Participants were enrolled between 21 October 2024 and 31 March 2025. Overall, 475 individuals were screened at 46 sites in China, of whom 375 entered the single-blind placebo run-in period. In total, 284 participants were randomly assigned to safiglipron 30 mg (_n_ = 70), safiglipron 60 mg (_n_ = 70), safiglipron 90 mg (_n_ = 72) or placebo (_n_ = 72). A total of 243 (85.6%) participants completed the 52-week treatment period: 64 (91.4%) in the safiglipron 30 mg group, 60 (85.7%) in the safiglipron 60 mg group, 60 (83.3%) in the safiglipron 90 mg group and 59 (81.9%) in the placebo group. Overall, 261 (91.9%) participants completed trial follow-up: 67 (95.7%), 64 (91.4%), 67 (93.1%) and 63 (87.5%), respectively. Over the 52-week treatment period, the most common reasons for treatment discontinuation were participant withdrawal (22 (7.7%)) and adverse events (12 (4.2%)) (Fig. [1](https://www.nature.com/articles/s41591-026-04651-9#Fig1)). **Fig. 1: CONSORT diagram.** ![Fig. 1: CONSORT diagram.](https://media.springernature.com/lw685/springer-static/image/art%3A10.1038%2Fs41591-026-04651-9/MediaObjects/41591_2026_4651_Fig1_HTML.png) [Full size image](https://www.nature.com/articles/s41591-026-04651-9/figures/1) Reasons for treatment discontinuation were classified according to the single primary reason recorded in the trial database. ‘Adverse event’ denotes discontinuation determined by the investigator to be caused by an adverse event, whereas ‘withdrawal by participant’ denotes voluntary discontinuation for personal reasons that did not involve an adverse event. Percentages were calculated using the number of participants randomly assigned to each group as the denominator. The asterisk indicates participants initially assigned to placebo received placebo during the 32-week placebo-controlled core period and switched to safiglipron 30 mg at week 33 for the 20-week extension. Demographic and baseline clinical characteristics were generally balanced across treatment groups (Table [1](https://www.nature.com/articles/s41591-026-04651-9#Tab1)). All participants were Asian. The mean age was 49.4 years (s.d. 9.9), 94 (33.1%) of 284 participan
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