A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Evaluate the Efficacy and Safety of HRS-7535 in Participants With Chronic Kidney Disease

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group and event-driven phase III clinical trial. The aim of this trial is to confirm the superiority of HRS-7535 over placebo in reducing the risks of renal outcomes and cardiovascular death among participants with chronic kidney disease (CKD) on the basis of standard of care

Start Date01 Jul 2026

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

NCT07528027

/ RecruitingPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 for the Treatment of Hypertension in Participants With Obesity or Overweight

The main objective of this study is to demonstrate the superior efficacy of HRS-7535 in controlling blood pressure compared to placebo in subjects with hypertension and overweight or obesity;

Start Date29 May 2026

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.

NCT07497880

/ Active, not recruitingPhase 2

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Safety and tolerability and other weight-related outcomes will also be evaluated.

Start Date06 Apr 2026

Sponsor / Collaborator

Kailera Therapeutics, Inc.

100 Clinical Results associated with Safiglipron

100 Translational Medicine associated with Safiglipron

100 Patents (Medical) associated with Safiglipron

Literatures (Medical) associated with Safiglipron

01 Jul 2026·EClinicalMedicine

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

Article

Author: Zhao, Meng ; Liao, Xiaohui ; Lu, Junfeng ; Zhu, Yan ; Xu, Jing ; Wang, Fang ; Zhang, Xianghua ; Fei, Dadong ; Li, Yufeng ; She, Dunmin ; Zhao, Dong ; Wang, Guang ; Dong, Chongzhou ; Wang, Wanmin ; Lin, Xiang ; Li, Lu ; Jiang, Chengyan ; Xu, Yimei ; Chen, Yinyin ; Fang, Chen ; Li, Yongfeng ; Shi, Xiaoguang ; Wang, Yajun ; Huang, Yong ; Wu, Hanli ; Zhang, Lihui ; Wang, Junhong ; Li, Yang ; Yan, Rui ; Li, Xiaohua ; Jin, Lie ; Dong, Xiaolin ; Zhou, Jun ; Dong, Shaoshao ; Wei, Feng ; Mu, Yahui ; Wang, Liyun ; Li, Xiaofeng ; Liu, Jiang ; Liu, Shuxin ; Jiao, Xuehua ; Lv, Rong ; Wang, Caili ; Bai, Yan ; Xu, Yan ; Huang, Feng ; Peng, Liang ; Chen, Jianghua ; Wan, Qin ; Zhang, Yawei ; Wang, Yufan ; Wang, Aifang ; Song, Chengwei ; Chen, Lei ; Jin, Hui ; Jin, Ping ; Yan, Yuehong ; Shen, Shuijuan ; Hu, Chenliang ; Cheng, Zhifeng ; Piao, Chengmei ; Liu, Gang ; Huang, Jiyi ; Yang, Lin ; Fu, Yanqin ; Li, Qifu ; Zhang, Tie ; Liu, Haixia ; Liu, Cangsang ; Zhang, Yanning ; Wu, Yiqiang ; Yang, Shufang ; Du, Xuanyi ; Pan, Yangbin ; Zhang, Yu ; Ye, Zi ; Wang, Hong ; Li, Ya ; Zhang, Dandan ; Du, Xiaoying ; Tang, Ying

Background:

The efficacy of non-peptide small-molecule glucagon-like peptide-1 (GLP-1) receptor agonists in diabetic kidney disease remains uncertain, particularly as add-on therapy to contemporary high-intensity treatments. We assessed HRS-7535, a novel oral small-molecule GLP-1 receptor agonist, in this population.

Methods:

SOLID-DKD was a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial conducted at 72 clinical sites in China. Adults with diabetic kidney disease (urinary albumin-to-creatinine ratio [UACR] 300-<3000 mg/g; estimated glomerular filtration rate [eGFR] ≥30 mL/min per 1.73 m²) were randomly assigned (1:1:1) via a central interactive web-response system, stratified by baseline UACR, concomitant SGLT2 inhibitor use, and finerenone use to once-daily oral HRS-7535 (30 mg or 90 mg) or placebo for 16 weeks. The primary endpoint was the relative change in UACR from baseline to week 16. This trial is registered at ClinicalTrials.gov (NCT06415214) and is completed.

Findings:

Between June 21, 2024, and March 30, 2025, 281 participants were randomised; 280 received at least one dose (30 mg: n = 93; 90 mg: n = 94; placebo: n = 93). Baseline median UACR was 763 mg/g; 181 (64.6%) participants were receiving SGLT2 inhibitors and 68 (24.3%) were receiving finerenone. At week 16, the placebo-corrected reduction in UACR with 90 mg was -32% (95% CI -43 to -18; treatment-policy estimand [intention-to-treat]) and -38% (-49 to -24; efficacy estimand [on-treatment analysis]); with 30 mg, -14% (-29 to 4) and -19% (-34 to -2), respectively. Compared with placebo, the mean difference in glycated haemoglobin with HRS-7535 90 mg was -1.09% (-1.32 to -0.86) and in body weight was -2.95% (-3.94 to -1.95). Adverse events were primarily mild-to-moderate gastrointestinal events during dose escalation. Serious adverse events occurred in 5 (5.4%), 4 (4.3%), and 2 (2.2%) participants in the 30 mg, 90 mg, and placebo groups. Discontinuation due to adverse events occurred in 3 (3.2%), 1 (1.1%), and 0 participants, respectively. No deaths occurred.

Interpretation:

HRS-7535 dose-dependently reduced albuminuria in patients with diabetic kidney disease receiving intensive contemporary therapy, with a short-term safety profile consistent with the GLP-1 receptor agonist class, supporting its evaluation in phase 3 renal outcome trials.

Funding:

Jiangsu Hengrui Pharmaceuticals.

01 Mar 2024·Diabetes, obesity & metabolism

Safety, pharmacokinetics and pharmacodynamics of HRS ‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial

Article

Author: Zhou, Renpeng ; Wang, Quanren ; Fan, Yang ; Shu, Chang ; Ye, Zi ; Zhang, Qian ; Qin, Huiling ; Du, Yijun ; Shen, Yu ; Feng, Sheng ; Hu, Wei ; Zhang, Qin ; Xu, Yimei ; Wu, Jingying

Abstract:

Aim:

To assess the safety, tolerability, pharmacokinetics (PKs) and pharmacodynamics of HRS‐7535, a novel glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), in healthy participants.

Materials and Methods:

This phase 1 trial consisted of single‐ascending dose (SAD), food effect (FE) and multiple‐ascending dose (MAD) parts. In the SAD part, participants were randomized (6:2) to receive HRS‐7535 (at doses of 15, 60 and 120 mg; administered orally once daily) or placebo. In the FE part, participants were randomized (8:2) to receive a single dose of 90‐mg HRS‐7535 or placebo, in both fed and fasted states. In the MAD part, participants were randomized (18:6) to receive daily HRS‐7535 (120 mg [30/60/90/120‐mg titration scheme]) or placebo for 28 days. The primary endpoints were safety and tolerability.

Results:

Nausea and vomiting were the most frequently reported AEs across all three parts. In the SAD part, the median Tmax was 5.98‐5.99 hours and the geometric mean t1/2 was 5.28‐9.08 hours across the HRS‐7535 dosing range. In the MAD part, the median Tmax was 5.98‐10.98 hours and the geometric mean t1/2 was 6.48‐8.42 hours on day 28 in participants on HRS‐7535. PKs were approximately dose‐proportional. On day 29 in the MAD part, the mean (percentage) reduction in body weight from baseline was 4.38 kg (6.63%) for participants who received HRS‐7535, compared with 0.8 kg (1.18%) for those participants who received a placebo.

Conclusions:

HRS‐7535 exhibited a safety and tolerability profile consistent with other GLP‐1RAs and showed PKs suitable for once‐daily dosing. These findings support further clinical development of HRS‐7535 for type 2 diabetes.

News (Medical) associated with Safiglipron

16 Sep 2026

·www.globenewswire.com

Kailera Therapeutics to Participate in September Investor Conferences

WALTHAM, Mass., Sept. 16, 2026 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (Nasdaq: KLRA) (Kailera), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today announced participation in the following investor conferences: Bernstein Insights: Healthcare Leaders and Disruptors - 3rd Annual Healthcare ForumWednesday, September 23, 2026, 9:40 a.m. ETFireside Chat with Jamie Coleman, Chief Commercial Officer Stifel 2026 Virtual Cardiometabolic ForumWednesday, September 30, 2026, 11:30 a.m. ETFireside Chat with Ron Renaud, Chief Executive Officer, Doug Pagán, Chief Financial Officer, and Scott Wasserman, Chief Medical Officer The live webcasts will be available on the Events page of Kailera’s investor website. A replay of the conference webcasts will be archived on the company's website for 90 days. About Kailera Therapeutics Kailera Therapeutics (Kailera) is a clinical-stage biotechnology company focused on elevating the next era of obesity care by progressing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. With an obesity-first focus, Kailera is advancing four clinical-stage product candidates leveraging multiple GLP-1-based mechanisms of action and routes of administration specifically designed to address critical needs in the current therapeutic landscape with a lead product candidate, ribupatide injection (also known as KAI-9531), that has the potential for the greatest weight loss. Ribupatide injection is in global Phase 3 trials as a once-weekly injectable GLP-1/GIP receptor dual agonist. Kailera is expanding the ribupatide franchise by developing a once-daily oral formulation with the goal of providing an oral option with the potential for compelling weight loss and highly differentiated tolerability. Additionally, Kailera is advancing the development of KAI-7535, a once-daily oral small molecule GLP-1 receptor agonist, and KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist. Kailera’s vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. Kailera is based in Waltham, MA. For more information, visit www.kailera.com and follow us on LinkedIn and X. Special Note Regarding Kailera Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the profile of product candidates, the potential of Kailera’s portfolio, market opportunities for product candidates, the competitive landscape, and participation in upcoming events. Forward-looking statements can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," “suggest,” "plan," “goal,” “vision,” "potential," "predict," "project," "should," "target," "will," "would," or similar expressions and the negatives of those terms. Kailera cannot assure you that the forward-looking statements in this press release will prove to be accurate. Information in this press release may also include statements relating to past performance, which should not be regarded as a reliable indicator of future performance. Forward-looking statements are based on current expectations and assumptions together with projections of the future which are inherently uncertain, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in clinical development, regulatory review, manufacturing, competition, market opportunities, reliance on third parties, estimates of capital requirements, needs for additional financing, and other important factors, including those discussed under the caption “Risk Factors” in Kailera’s filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release, and Kailera undertakes no obligation to update or revise any forward-looking statements. Kailera may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Contact Information Maura Gavaghan Vice President, Investor Relations maura.gavaghan@kailera.com Anna RobinsonVice President, Communicationsanna.robinson@kailera.com

Phase 3

16 Sep 2026

·www.biospace.com

Kailera Therapeutics to Participate in September 2026 Investor Conferences

WALTHAM, Mass., Sept. 16, 2026 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (Nasdaq: KLRA) (Kailera), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today announced participation in the following investor conferences: Bernstein Insights: Healthcare Leaders and Disruptors - 3rd Annual Healthcare Forum Wednesday, September 23, 2026, 9:40 a.m. ET Fireside Chat with Jamie Coleman, Chief Commercial Officer Stifel 2026 Virtual Cardiometabolic Forum Wednesday, September 30, 2026, 11:30 a.m. ET Fireside Chat with Ron Renaud, Chief Executive Officer, Doug Pagán, Chief Financial Officer, and Scott Wasserman, Chief Medical Officer The live webcasts will be available on the Events page of Kailera’s investor website. A replay of the conference webcasts will be archived on the company's website for 90 days. About Kailera Therapeutics Kailera Therapeutics (Kailera) is a clinical-stage biotechnology company focused on elevating the next era of obesity care by progressing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. With an obesity-first focus, Kailera is advancing four clinical-stage product candidates leveraging multiple GLP-1-based mechanisms of action and routes of administration specifically designed to address critical needs in the current therapeutic landscape with a lead product candidate, ribupatide injection (also known as KAI-9531), that has the potential for the greatest weight loss. Ribupatide injection is in global Phase 3 trials as a once-weekly injectable GLP-1/GIP receptor dual agonist. Kailera is expanding the ribupatide franchise by developing a once-daily oral formulation with the goal of providing an oral option with the potential for compelling weight loss and highly differentiated tolerability. Additionally, Kailera is advancing the development of KAI-7535, a once-daily oral small molecule GLP-1 receptor agonist, and KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist. Kailera’s vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. Kailera is based in Waltham, MA. For more information, visit and follow us on LinkedIn and X . Special Note Regarding Kailera Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the pro product candidates, the potential of Kailera’s portfolio, market opportunities for product candidates, the competitive landscape, and participation in upcoming events. Forward-looking statements can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," “suggest,” "plan," “goal,” “vision,” "potential," "predict," "project," "should," "target," "will," "would," or similar expressions and the negatives of those terms. Kailera cannot assure you that the forward-looking statements in this press release will prove to be accurate. Information in this press release may also include statements relating to past performance, which should not be regarded as a reliable indicator of future performance. Forward-looking statements are based on current expectations and assumptions together with projections of the future which are inherently uncertain, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in clinical development, regulatory review, manufacturing, competition, market opportunities, reliance on third parties, estimates of capital requirements, needs for additional financing, and other important factors, including those discussed under the caption “Risk Factors” in Kailera’s filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release, and Kailera undertakes no obligation to update or revise any forward-looking statements. Kailera may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Contact Information Maura Gavaghan Vice President, Investor Relations maura.gavaghan@kailera.com Anna Robinson Vice President, Communications anna.robinson@kailera.com

03 Sep 2026

·allsci.com

Hengrui files Kailera-partnered oral GLP-1 for China approval in obesity and diabetes

China's drug regulator has accepted a marketing authorization application for HRS-7535 tablets, an oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist developed by Jiangsu Hengrui Pharmaceutical Co. (HKEX: 01276), for long-term weight management in adults with obesity or overweight. The filing, submitted through Hengrui's subsidiary Shandong Shengdi Pharmaceutical, covers adults with a body mass index (BMI) of 28 kg/m² or above, or 24 kg/m² or above accompanied by at least one weight-related comorbidity. The submission follows positive topline results from the Phase III HARBOR-1 trial, in which 556 adults across 50 centers in China received once-daily HRS-7535 at 120 mg or 180 mg, or placebo. All dose groups met the primary and key secondary endpoints at 44 weeks. The 180 mg group achieved mean weight loss of 10.9% at week 44, extending to 11.1% at week 50 with continued treatment. Improvements in cardiometabolic indicators were also reported. The company said safety and tolerability were consistent with other oral GLP-1 therapies, with no new safety signals and a favorable hepatic safety profile — a feature the filing highlights given the high co-prevalence of fatty liver disease in the target Chinese patient population. One day earlier, on September 2, Hengrui disclosed that the National Medical Products Administration (NMPA) had also accepted a separate marketing application for HRS-7535 in type 2 diabetes, supported by the Phase III OUTSTAND-1 and OUTSTAND-2 trials. Across both studies, HRS-7535 reduced HbA1c by 1.40% to 1.68% across dose groups, with the 90 mg dose demonstrating superiority to dapagliflozin in OUTSTAND-2. HRS-7535 acts as a non-peptide oral agonist of the GLP-1 receptor which can be formulated as a conventional oral tablet. In terms of the Chinese market conditions for obesity, both leading injectables, semaglutide (Wegovy) and tirzepatide (Mounjaro), received NMPA approval in 2024. No oral small-molecule GLP-1R agonist is currently marketed in China. Globally, Eli Lilly’s orforglipron (Foundayo) received US FDA approval in April 2026, validating the oral small-molecule GLP-1 class commercially. HRS-7535 would bring that approach into a Chinese obesity market currently dominated by injectable incretins. Kailera Therapeutics (Nasdaq: KLRA), which licensed HRS-7535 outside Greater China in 2024 under the name KAI-7535, is evaluating the drug in a global Phase II obesity study in the US and Australia, with data expected in 2027. The trial is testing a broader dose range and slower titration schedule than HARBOR-1, with tolerability likely to be an important focus after gastrointestinal adverse events including nausea and vomiting were common in the China study. Spot something wrong? Report an issue with this article

Phase 3Clinical ResultDrug ApprovalPhase 2

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	China	Shandong Suncadia Medicine Co., Ltd.	03 Sep 2026
Chronic Kidney Diseases	Phase 3	China	Shandong Suncadia Medicine Co., Ltd.	01 Jul 2026
Hypertension	Phase 3	China	Shandong Suncadia Medicine Co., Ltd.	28 Apr 2026
Obesity	Phase 3	China	Shandong Suncadia Medicine Co., Ltd.	09 Apr 2025
Chronic heart failure	Phase 2	China	Shandong Suncadia Medicine Co., Ltd.	10 Apr 2025
Heart failure with normal ejection fraction	Phase 2	China	Shandong Suncadia Medicine Co., Ltd.	10 Apr 2025
Diabetic Nephropathies	Phase 2	China	Shandong Suncadia Medicine Co., Ltd.	21 Jun 2024
Type 2 diabetes mellitus with established diabetic nephropathy	Phase 2	China	Shandong Suncadia Medicine Co., Ltd.	17 Jun 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06415214 (SOLID-DKD, Pubmed \| EClinicalMedicine)	Phase 2	Diabetic Nephropathies	280	HRS-7535 30 mg	zmsdtrfmhq(tltrjqrbli) = ktvdbttzci aqotdwkoqr (nzsuofqajz, -34 to -2) View more	Positive	01 Jul 2026
				HRS-7535 90 mg	zmsdtrfmhq(tltrjqrbli) = vmfnzvbxgc aqotdwkoqr (nzsuofqajz, -49 to -24) View more
NCT05759897 (Pubmed \| JAMA Netw Open)	Phase 2	Diabetes Mellitus, Type 2	194	HRS-7535 15 mg	mocjgusagj(nhjmknzlde) = bmupxdmjdo subnubbgrt (sqsyjbhoox, 32.4 - 65.2) View more	Positive	03 Jun 2026
				HRS-7535 30 mg	qsxpleyeql(hnoorokpgr) = ujcuckgnbl iedhgzrbew (fvgldbagez )
NCT06415214 (ASN2025 \| NEWS)	Phase 2	Diabetic Nephropathies	281	HRS-7535 30 mgHRS-7535 30 mg	epfkmffsyd(rmzwibxiph) = sappnqjygr tkpapcbziw (aoxosuvlgm ) View more	Positive	07 Nov 2025
				HRS-7535 90 mgHRS-7535 90 mg	epfkmffsyd(rmzwibxiph) = ohobymbjsf tkpapcbziw (aoxosuvlgm ) View more
NCT05759897 (ADA 12025 \| ADA 22025 \| NEWS) Manual	Phase 2	Diabetes Mellitus, Type 2	194	HRS-7535 15mg	auyzpzbgxi(lutucvitic) = pjtsqiiqlq fotifxsmbz (fbeyqnkqnz ) View more	Positive	20 Jun 2025
				HRS-7535 30mg	auyzpzbgxi(lutucvitic) = jlnvozebfy fotifxsmbz (fbeyqnkqnz ) View more
ADA 12025 \| ADA 22025	Phase 2	Obesity	235	HRS-7535 30 mgHRS-7535 30 mg	jyzkiewrxe(vueynygytx) = uxughtooow eamkggplcz (ypnobgeexw ) View more	Positive	20 Jun 2025
				HRS-7535 60 mgHRS-7535 60 mg	jyzkiewrxe(vueynygytx) = dchwybaopi eamkggplcz (ypnobgeexw )
CTR20240369 (NEWS) Manual	Phase 2	Overweight \| Obesity	235	HRS-7535 30mg	uilizbagpy(dlxkdkmpdz) = mddjbzgger hcvbllabws (vatzkpmlyq )	Positive	17 Jun 2025
				HRS-7535 60mg	uilizbagpy(dlxkdkmpdz) = jnrcedzfwu hcvbllabws (vatzkpmlyq )
NCT05347758 (EASD2023)	Phase 1	-	24	HRS-7535 15 mg	limyozyjat(bvqnejiuew) = Most common treatment-emergent adverse events in both SAD and MAD were nausea lizsntuuzy (hoqogiwtwy ) View more	Positive	03 Oct 2023
				HRS-7535 60 mg
NCT05347758 (ADA 12023 \| ADA 22023) Manual	Phase 1	-	48	HRS-7535 (SAD)	fyaiydmdal(yqoxfxvpxs) = Most common treatment-emergent adverse events in both SAD and MAD were nausea and vomiting; all TEAEs were mild in severity. dnbimcdjwx (mpodzzwahy ) View more	Positive	20 Jun 2023
				HRS-7535 (MAD)

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