KAI-7535: Another Oral GLP-1 Pill Clears Phase 3 — With a Clean Liver-Safety Readout (August 2, 2026)
Table of Contents
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.
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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) Source
- [2] Kailera Reports First Quarter 2026 Financial Results and Provides Clinical Data Updates Source
- [3] HARBOR-1 (HRS-7535-303) — ClinicalTrials.gov NCT06904105 Source
- [4] OUTSTAND-2 (HRS-7535-302) — ClinicalTrials.gov NCT06589765 Source
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