HRS-7535 / Jiangsu Hengrui Pharma, Kailera Therapeutics - LARVOL DELTA

HRS-7535 Effect on Glycaemic Status in Prediabetes: HARBOR-1 Subgroup Analysis (OBESITY WEEK 2026) - No abstract available

Metabolic Disorders

HRS-7535 for Weight Management in Chinese Adults with Overweight or Obesity: Phase 3 HARBOR-1 Study (OBESITY WEEK 2026) - No abstract available

Clinical • P3 data • Genetic Disorders • Obesity

Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity (clinicaltrials.gov) - P2 | N=306 | Active, not recruiting | Sponsor: Kailera | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Oral HRS-7535 versus dapagliflozin in Chinese adults with type 2 diabetes inadequately controlled with metformin: the OUTSTAND-2 Phase 3 trial (EASD 2026) - P3 | "In Chinese adults with T2D inadequately controlled with metformin, once-daily oral HRS-7535 was non-inferior to dapagliflozin for week 32 HbA1c reduction across doses, with treatment differences favouring HRS-7535 and superiority at 90 mg. HRS- 7535 improved HbA1c target attainment and multiple cardiometabolic measures, with a GLP-1RA-consistent safety profile. Without fasting restrictions, HRS-7535 may provide a convenient oral option for this population."

Clinical • Late-breaking abstract • P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Oral small-molecule GLP-1 RA HRS-7535 as monotherapy in Chinese adults with early type 2 diabetes: the OUTSTAND-1 Phase 3 trial (EASD 2026) - P3 | "HRS-7535 monotherapy significantly improved glycemic control and multiple cardiometabolic risk factors in Chinese adults living with T2DM and demonstrated a safety profile consistent with the GLP-1 RA class. As an oral GLP-1 RA without fasting restrictions, HRS-7535 may offer a convenient option for early intervention in T2DM."

Clinical • Late-breaking abstract • Monotherapy • P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

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 (AllSci Corp) - "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."

China filing • Obesity

…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 (AllSci Corp) - "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."

China filing • Type 2 Diabetes Mellitus

A Study of Safety and Tolerability of Multiple Doses of HRS-7535 in Obese Subjects (clinicaltrials.gov) - P1/2 | N=74 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Anticipated Key Milestones (GlobeNewswire) - "KAI-7535: Global Phase 2 obesity data anticipated in 2027; (ii) KAI-4729: Phase 1 trial initiation anticipated by end of year 2026; data anticipated in 2027"

New P1 trial • P1 data • P2 data • Obesity

A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity (clinicaltrials.gov) - P3 | N=556 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

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. (PubMed, EClinicalMedicine) - P2 | "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. 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. Jiangsu Hengrui Pharmaceuticals."

Journal • P2 data • Diabetic Nephropathy • Nephrology • Renal Disease

About the KAI-7535 Phase 2 Global Trial (GlobeNewswire) - "The trial initiated in April 2026, with data expected in 2027...The KAI-7535 Phase 2 global trial is a multicenter, randomized, double-blind, placebo-controlled conducted by Kailera in the U.S. and Australia....is expected to enroll approximately 320 adult participants with a BMI of 30 or greater, or a BMI of 27 or greater with at least one co-morbidity, which may include T2D."

P2 data • Trial status • Obesity • Type 2 Diabetes Mellitus

HARBOR-1: HRS-7535 (KAI-7535) Phase 3 Trial in Obesity (GlobeNewswire) - "HARBOR-1 met its primary endpoint, achievement of superior weight reduction at Week 44 with HRS-7535 compared to placebo...Based on the efficacy estimand, participants taking HRS-7535 120 mg and 180 mg achieved a mean weight loss of 9.5% and 10.9% from baseline at Week 44, respectively, compared to 2.5% with placebo; Based on the treatment policy estimand, participants taking HRS-7535 120 mg and 180 mg achieved a mean weight loss of 8.0% and 9.8% from baseline at Week 44, respectively, compared to 2.4% with placebo; Based on the treatment policy estimand, at Week 44, 58.6% (120 mg) and 68.2% (180 mg) of HRS-7535 treated participants achieved at least 5% weight loss...Hengrui Pharma intends to share the full HARBOR-1 and OUTSTAND-2 clinical trial data at upcoming scientific conferences and plans to submit NDAs for HRS-7535 for the treatment of T2D and obesity in China."

China filing • P3 data: top line • Obesity • Type 2 Diabetes Mellitus

OUTSTAND-2: A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin (clinicaltrials.gov) - P3 | N=810 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Feb 2026 ➔ May 2026

Trial completion • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

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. (PubMed, Nat Commun) - P2 | "Gastrointestinal adverse events were the most common, were predominantly mild to moderate, and occurred more frequently during dose escalation. Overall, once-daily oral HRS-7535 at doses of 60 mg or higher produced clinically meaningful weight loss and was generally well tolerated.Trial registration: ClinicalTrials.gov identifier NCT06250946."

Clinical • Journal • P2 data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

RENEW-CKD: Renal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease (clinicaltrials.gov) - P3 | N=3690 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Phase III Study of HRS-7535 for Hypertension With Overweight or Obesity (clinicaltrials.gov) - P3 | N=648 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Genetic Disorders • Hypertension • Obesity

KAI-7535, oral small molecule GLP-1 receptor agonist (GlobeNewswire) - "The double-blind, randomized, placebo-controlled trial is expected to enroll approximately 320 participants with a BMI of 30+ or a BMI of 27+ with at least one co-morbidity, which may include T2D. Participants will receive either placebo or doses up to 360 mg of KAI-7535 administered over a period of 44 weeks. Data is anticipated in 2027....plans to submit an NDA for HRS-7535 for the treatment of T2D in China."

China filing • P2 data • Trial status • Obesity • Type 2 Diabetes Mellitus

HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial. (PubMed, JAMA Netw Open) - P2 | "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. ClinicalTrials.gov Identifier: NCT05759897."

Clinical • Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Pancreatitis • Type 2 Diabetes Mellitus

A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise (clinicaltrials.gov) - P3 | N=284 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed | N=18 ➔ 24

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Kailera | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

HRS-7535-105: Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

HRS-7535-108: Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed | N=54 ➔ 18

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase III Study of HRS-7535 for Hypertension With Overweight or Obesity (clinicaltrials.gov) - P3 | N=648 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Cardiovascular • Genetic Disorders • Hypertension • Obesity