--- title: "KAI-7535: Another Oral GLP-1 Pill Clears Phase 3 — With a Clean Liver-Safety Readout (August 2, 2026) | PepTracker Pro Blog" description: "The oral GLP-1 pill race just added another late-stage entrant. Hengrui's HRS-7535 — developed outside China by Kailera as KAI-7535 — posted up to 10.9% weight loss at Week 44 in a Chinese Phase 3 obesity trial and beat dapagliflozin on blood sugar in a diabetes trial, with no liver-safety signal. Here is what the data show and where it sits versus orforglipron and aleniglipron." lang: en json-ld: | [ { "@context": "https://schema.org", "@type": "Organization", "name": "PepTracker Pro", "url": "https://peptrackerpro.com", "logo": "https://peptrackerpro.com/favicon.png", "description": "Evidence-based educational resource dedicated to improving peptide research literacy.", "contactPoint": { "@type": "ContactPoint", "email": "hello@peptrackerpro.com", "contactType": "customer support" }, "sameAs": [] }, { "@context": "https://schema.org", "@type": "Article", "headline": "KAI-7535: Another Oral GLP-1 Pill Clears Phase 3 — With a Clean Liver-Safety Readout (August 2, 2026)", "description": "The oral GLP-1 pill race just added another late-stage entrant. Hengrui's HRS-7535 — developed outside China by Kailera as KAI-7535 — posted up to 10.9% weight loss at Week 44 in a Chinese Phase 3 obesity trial and beat dapagliflozin on blood sugar in a diabetes trial, with no liver-safety signal. Here is what the data show and where it sits versus orforglipron and aleniglipron.", "datePublished": "2026-08-02", "dateModified": "2026-08-02", "author": { "@type": "Organization", "name": "PepTracker Pro Research Team", "url": "https://peptrackerpro.com" }, "publisher": { "@type": "Organization", "name": "PepTracker Pro", "logo": { "@type": "ImageObject", "url": "https://peptrackerpro.com/favicon.png" } }, "mainEntityOfPage": { "@type": "WebPage", "@id": "https://peptrackerpro.com/blog/kai-7535-hrs-7535-hengrui-kailera-oral-small-molecule-glp1-harbor-1-outstand-2-phase3-liver-safety-obesity-august-2-2026" } }, { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://peptrackerpro.com" }, { "@type": "ListItem", "position": 2, "name": "Blog", "item": "https://peptrackerpro.com/blog" }, { "@type": "ListItem", "position": 3, "name": "KAI-7535: Another Oral GLP-1 Pill Clears Phase 3 — With a Clean Liver-Safety Readout (August 2, 2026)", "item": "https://peptrackerpro.com/blog/kai-7535-hrs-7535-hengrui-kailera-oral-small-molecule-glp1-harbor-1-outstand-2-phase3-liver-safety-obesity-august-2-2026" } ] } ] --- [Skip to main content](#main) **Educational information only.** This site does not provide medical advice. [Read full disclaimer](/disclaimer) [PepTracker Pro](/) [Home](/)[Peptides](/peptides)[Compare](/compare)[Glossary](/glossary)[Blog](/blog)[Calculators](/calculators)[Start Here](/start) [Open the App](https://app.peptrackerpro.com) [Blog](/blog)/ KAI-7535: Another Oral GLP-1 Pill Clears Phase 3 — With a Clean Liver-Safety Readout (August 2, 2026) Research & Compounds Research & Compounds # KAI-7535: Another Oral GLP-1 Pill Clears Phase 3 — With a Clean Liver-Safety Readout (August 2, 2026) PepTracker Pro Research Team August 2, 2026 7 min read ## Table of Contents - [Why another oral GLP-1 matters](#section-0) - [What KAI-7535 (HRS-7535) actually is](#section-1) - [HARBOR-1: the obesity result](#section-2) - [OUTSTAND-2: the diabetes result](#section-3) - [The liver-safety headline](#section-4) - [Where it sits versus orforglipron and aleniglipron](#section-5) - [Status and what to watch](#section-6) ## Why another oral GLP-1 matters Injectable GLP-1 drugs reshaped obesity care, but the next frontier is a once-daily pill. A small-molecule GLP-1 receptor agonist that can be swallowed avoids the cold-chain storage, specialized manufacturing, and injection burden of peptide drugs — which is what makes oral candidates like orforglipron and aleniglipron so closely watched. KAI-7535 is now one of the most advanced entrants in that race, and on July 7, 2026 it delivered two positive Phase 3 readouts at once. ## What KAI-7535 (HRS-7535) actually is KAI-7535 is the development name Kailera Therapeutics uses for HRS-7535, an oral once-daily small-molecule GLP-1 receptor agonist discovered by China's Jiangsu Hengrui Pharmaceuticals. Hengrui licensed rights outside Greater China to Kailera in 2024. It is a non-peptide compound — meaning it mimics the appetite- and glucose-regulating actions of GLP-1 without being a peptide that has to be injected. More than 2,000 patients have been dosed with HRS-7535 in Chinese trials, giving it an unusually deep safety database for a program at this stage. ## HARBOR-1: the obesity result HARBOR-1 (HRS-7535-303, NCT06904105) enrolled 556 adults in China with overweight or obesity (mean baseline weight 94.1 kg, mean BMI 34.0) and randomized them to once-daily HRS-7535 120 mg, 180 mg, or placebo. It met its primary endpoint: on the efficacy estimand, the 120 mg and 180 mg arms lost a mean 9.5% and 10.9% of body weight at Week 44 versus 2.5% for placebo, and weight loss continued to Week 50 (9.5% and 11.1% vs 2.6%). On the more conservative treatment-policy estimand the arms lost 8.0% and 9.8% versus 2.4%. Among responders on the 180 mg dose, 68.2% lost at least 5% of body weight, 46.6% at least 10%, and 26.0% at least 15% — with improvements also seen in HbA1c, systolic blood pressure, and lipids. ## OUTSTAND-2: the diabetes result The second Phase 3 trial, OUTSTAND-2 (HRS-7535-302, NCT06589765), tested HRS-7535 against the SGLT2 inhibitor dapagliflozin in 810 Chinese adults with type 2 diabetes inadequately controlled on metformin (mean baseline HbA1c 8.60%). At Week 32, HRS-7535 at 30, 60, and 90 mg met non-inferiority to dapagliflozin, and the 90 mg dose was statistically superior on HbA1c reduction: drops of 1.58%, 1.50%, and 1.68% across doses versus 1.28% for dapagliflozin, plus improvements in weight, blood pressure, lipids, and the urinary albumin-to-creatinine ratio. ## The liver-safety headline The most strategically important line in the readout may be a negative one: no liver safety signal was observed in either trial, consistent with prior HRS-7535 data. Hepatic-safety questions have dogged the oral small-molecule GLP-1 field and helped end at least one earlier program, so a clean liver profile across large Phase 3 trials is a meaningful differentiator. Tolerability otherwise looked like the class: mostly mild-to-moderate gastrointestinal effects — in HARBOR-1, nausea around 70%, vomiting around 67%, and diarrhea around 36% on active drug — but treatment discontinuation due to adverse events was low, at roughly 3–4%. ## Where it sits versus orforglipron and aleniglipron KAI-7535's ~11% Week-50 weight loss lands below the high bar aleniglipron set in its 44-week Phase 2 (about 16% placebo-adjusted) and in the same neighborhood as orforglipron's oral GLP-1 results, though cross-trial comparisons are unreliable because trial designs, populations, doses, and titration schedules differ. Notably, the pivotal KAI-7535 efficacy data so far come only from China. That is exactly why Kailera is running a separate global Phase 2 trial — launched April 2026 in the U.S. and Australia in about 320 participants — that starts at a lower 15 mg dose and titrates more gradually (up to 180 mg, with a higher cohort to 360 mg) to fine-tune the weight-loss-versus-tolerability balance before global Phase 3. Data are expected in 2027. ## Status and what to watch KAI-7535 is investigational and not approved anywhere. Hengrui plans to submit China NDAs for HRS-7535 in both obesity and type 2 diabetes, while Kailera's global program advances the same molecule for Western markets. It is the oral small-molecule sibling to Kailera's lead injectable GLP-1/GIP dual agonist ribupatide (KAI-9531). Anything sold online as 'KAI-7535' or 'HRS-7535' is unverified — this is a clinical-stage pharmaceutical, not a supplement or research chemical. Watch for the global Phase 2 readout in 2027 and for full HARBOR-1/OUTSTAND-2 data at upcoming scientific conferences. Ready to track your peptide research? [Open PepTracker Pro](https://app.peptrackerpro.com) PepTracker Pro Research Team The PepTracker Pro Research Team is an editorial group of science writers, pharmacologists, and clinical researchers dedicated to making peptide science accessible. Every article is reviewed for accuracy against peer-reviewed sources and updated as new evidence emerges. ## Citations 1. \[1\] Kailera Therapeutics — Positive Topline Data from Two Hengrui Phase 3 Trials of Oral GLP-1 HRS-7535/KAI-7535 (July 7, 2026) [Source](https://www.globenewswire.com/news-release/2026/07/07/3323036/0/en/kailera-therapeutics-announces-positive-topline-data-from-two-hengrui-pharma-phase-3-clinical-trials-of-oral-small-molecule-glp-1-receptor-agonist-hrs-7535-kai-7535.html) 2. \[2\] Kailera Reports First Quarter 2026 Financial Results and Provides Clinical Data Updates [Source](https://investors.kailera.com/news-releases/news-release-details/kailera-reports-first-quarter-2026-financial-results-and) 3. \[3\] HARBOR-1 (HRS-7535-303) — ClinicalTrials.gov NCT06904105 [Source](https://clinicaltrials.gov/study/NCT06904105) 4. \[4\] OUTSTAND-2 (HRS-7535-302) — ClinicalTrials.gov NCT06589765 [Source](https://clinicaltrials.gov/study/NCT06589765) **Disclaimer:** This article is for educational purposes only and does not constitute medical advice. 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