KAI-7535
Medium EvidenceAn oral once-daily small-molecule GLP-1 receptor agonist (Hengrui's HRS-7535, licensed to Kailera) that delivered up to 10.9% weight loss at Week 44 in a Chinese Phase 3 obesity trial and met its Phase 3 diabetes endpoint, now in a global Phase 2 dose-optimization study.
What It Is
KAI-7535 (Hengrui Pharma's HRS-7535) is an investigational once-daily oral small-molecule GLP-1 receptor agonist being developed for obesity and type 2 diabetes. Like orforglipron and aleniglipron, it is a non-peptide compound intended to sidestep the manufacturing complexity, cold-chain storage, and injection burden of peptide-based GLP-1 drugs while offering the convenience of a daily pill. HRS-7535 was discovered by Jiangsu Hengrui Pharmaceuticals and licensed to Kailera Therapeutics outside Greater China in 2024; Kailera develops it as KAI-7535. More than 2,000 patients have been dosed with HRS-7535 in Chinese clinical trials to date. On July 7, 2026, Kailera announced positive topline data from two Hengrui-run Phase 3 trials in China. In the HARBOR-1 obesity trial (HRS-7535-303, NCT06904105; 556 adults with overweight or obesity, mean baseline weight 94.1 kg and BMI 34.0), once-daily HRS-7535 met its primary endpoint of superior weight reduction at Week 44: participants on 120 mg and 180 mg lost a mean 9.5% and 10.9% of body weight (efficacy estimand) versus 2.5% for placebo, with continued loss to Week 50 (9.5% and 11.1% vs 2.6%). On the treatment-policy estimand the 120 mg and 180 mg arms lost 8.0% and 9.8% versus 2.4%, and at Week 44 up to 68.2% of treated participants achieved at least 5% weight loss, 46.6% at least 10%, and 26.0% at least 15%. In the OUTSTAND-2 diabetes trial (HRS-7535-302, NCT06589765; 810 adults with type 2 diabetes), HRS-7535 at 30/60/90 mg met non-inferiority to dapagliflozin on HbA1c at Week 32, with the 90 mg dose achieving statistically superior HbA1c reduction (1.58%, 1.50%, and 1.68% across doses vs 1.28% for dapagliflozin). No liver safety signal was observed in either trial, consistent with prior HRS-7535 data — a notable point given that hepatic-safety questions have shadowed some oral small-molecule GLP-1 programs. Adverse events were predominantly mild-to-moderate gastrointestinal effects (in HARBOR-1, nausea ~70%, vomiting ~67%, diarrhea ~36% on active drug), with treatment discontinuation from adverse events of only 3–4%. Kailera is separately running a global Phase 2 trial of KAI-7535 (initiated April 2026 in the U.S. and Australia, ~320 participants) that uses a lower 15 mg starting dose and a more gradual titration up to 180 mg (with a higher-dose cohort to 360 mg) to optimize the balance of weight loss and tolerability, with data expected in 2027. Hengrui plans to submit China NDAs for HRS-7535 in both obesity and type 2 diabetes. KAI-7535 is the oral small-molecule sibling to Kailera's lead injectable GLP-1/GIP dual agonist ribupatide (KAI-9531) within a broader Kailera obesity portfolio.
Regulatory Status
Two Chinese Phase 3 trials (HARBOR-1 obesity, OUTSTAND-2 T2D) reported positive topline results July 7, 2026; Hengrui plans China NDA submissions for obesity and type 2 diabetes. Kailera's global (U.S./Australia) Phase 2 dose-optimization trial initiated April 2026 with data expected 2027. Not approved for any indication anywhere.
Effective: July 2026
View FDA SourceWhy Researchers Study It
KAI-7535 is one of the most clinically advanced oral small-molecule GLP-1 receptor agonists, with two positive Phase 3 readouts already in hand from China and more than 2,000 patients dosed. Researchers watch it as a scalable, room-temperature-stable daily pill that could broaden access to incretin therapy, and as a test of whether the oral small-molecule GLP-1 class can deliver competitive weight loss while avoiding the liver-safety issues that ended earlier programs. Its clean liver-safety profile across large Phase 3 trials is a particular point of interest.
Proposed Mechanisms
- Small-molecule agonism of the GLP-1 receptor, reducing appetite and caloric intake
- Delays gastric emptying to promote satiety
- Enhances glucose-dependent insulin secretion, lowering HbA1c
- Non-peptide oral structure enables once-daily dosing without the cold chain of injectable peptides
Evidence Snapshot
| Study Type | Model | Outcome | Link |
|---|---|---|---|
| Phase 3 (HARBOR-1, obesity, China) | 556 adults with overweight/obesity, mean BMI 34.0 — 44–50 weeks | Met primary endpoint: 120 mg and 180 mg achieved mean weight loss of 9.5% and 10.9% at Week 44 (efficacy estimand) vs 2.5% placebo; up to 11.1% at Week 50; up to 26.0% of participants reached ≥15% weight loss; no liver safety signal | Source |
| Phase 3 (OUTSTAND-2, type 2 diabetes, China) | 810 adults with T2D on metformin, mean baseline HbA1c 8.60% — 32 weeks core | Met primary endpoint: non-inferiority to dapagliflozin across 30/60/90 mg; HbA1c reductions of 1.58%, 1.50%, 1.68% vs 1.28% for dapagliflozin (90 mg statistically superior); improvements in weight, blood pressure, lipids and UACR; no liver safety signal | Source |
| Phase 2 (global dose-optimization, U.S./Australia) | ~320 adults with obesity (BMI ≥30, or ≥27 with a comorbidity) — 44-week treatment | Ongoing: initiated April 2026, evaluating a lower 15 mg starting dose with gradual titration to 180 mg (higher cohort to 360 mg) to optimize weight loss versus tolerability; topline data expected 2027 | Source |
Commonly Discussed Benefits
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Safety & Cautions
- Investigational — not approved for any use anywhere
- Pivotal efficacy data to date come from China-only Phase 3 trials; global Phase 2/3 confirmation is still underway
- Gastrointestinal adverse events are common (nausea, vomiting, diarrhea), mostly during dose titration
- As a GLP-1 receptor agonist, class effects and long-term safety monitoring apply
- Any 'KAI-7535' or 'HRS-7535' offered by a vendor is unverified — this is a clinical-stage pharmaceutical, not a supplement or research chemical
Comparisons
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Citations
- [1] Kailera Therapeutics — Positive Topline Data from Two Hengrui Phase 3 Trials of Oral GLP-1 HRS-7535/KAI-7535 (July 7, 2026) PubMed
- [2] Kailera Reports First Quarter 2026 Financial Results and Provides Clinical Data Updates (KAI-7535 global Phase 2) PubMed
- [3] HARBOR-1 (HRS-7535-303) — ClinicalTrials.gov NCT06904105 PubMed
- [4] OUTSTAND-2 (HRS-7535-302) — ClinicalTrials.gov NCT06589765 PubMed
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