Kailera Therapeutics Inc. (NASDAQ:KLRA) stock fell about 9% on Tuesday after the company reported positive topline results from two Phase 3 trials of its oral GLP-1 drug candidate HRS-7535/KAI-7535 in China.
Investors focused instead on the treatment’s gastrointestinal side effects, with nausea and vomiting reported at high rates in the obesity study, according to Reuters.
Obesity Trial Meets Primary Endpoint
The company said its Phase 3 HARBOR-1 (obesity/overweight) and OUTSTAND-2 (type 2 diabetes) studies met their primary endpoints.
Kailera is concurrently advancing KAI-7535 in a global Phase 2 trial for obesity or overweight. The trial was initiated in April 2026, with data expected in 2027.
The HARBOR-1 Phase 3 study achieved its primary endpoint by showing superior weight reduction with HRS-7535 versus placebo at Week 44.
Based on the efficacy estimand, patients receiving the 120 mg and 180 mg doses recorded mean weight loss of 9.5% and 10.9%, respectively, compared with 2.5% for placebo.
Under the treatment policy estimand, mean weight loss was 8.0% and 9.8% versus 2.4% with placebo.
The trial also showed that, by Week 44, 58.6% of patients receiving 120 mg and 68.2% receiving 180 mg achieved at least 5% weight loss. Meanwhile, 39.6% and 46.6% reached at least 10% weight loss, while 18.5% and 26.0%, respectively, achieved reductions of at least 15%.
An ad hoc analysis at Week 50 showed mean weight loss of 9.5% and 11.1% for the two HRS-7535 doses, compared with 2.6% for placebo. Improvements were also reported in HbA1c, systolic blood pressure and lipid profiles.
The most common side effects were nausea and vomiting, reported in about 70% and more than 65% of patients receiving the drug, respectively, compared with 16.2% and 4.5% in the placebo group.
“In our view, reducing the rate of nausea and vomiting to roughly mid-30% and mid-20%, respectively, will yield a competitive profile,” said William Blair analyst Andy Hsieh.
Diabetes Study Shows HbA1c Improvement Versus Dapagliflozin
The OUTSTAND-2 Phase 3 trial met its primary endpoint by demonstrating non-inferiority to dapagliflozin across all HRS-7535 dose levels.
The 90 mg dose also achieved a statistically significant reduction in HbA1c compared with dapagliflozin at Week 32.
Based on the efficacy estimand, HbA1c declined by 1.58%, 1.50% and 1.68% in the 30 mg, 60 mg, and 90 mg HRS-7535 groups, respectively, compared with a 1.28% reduction for patients receiving dapagliflozin.
Researchers also observed improvements in body weight, systolic blood pressure, lipid profiles and urinary albumin-to-creatinine ratio.
Safety Profile Remains Consistent
Across both studies, most treatment-emergent adverse events were mild to moderate and primarily gastrointestinal in nature.
The company reported no liver safety signal in either trial, consistent with earlier studies, while the diabetes study also reported no Grade 3 hypoglycemic events.
Hsieh said, “We believe KAI-7535’s efficacy has the potential to be competitive in both chronic weight management and type 2 diabetes.”
From a stock perspective, the analyst views Kailera’s broad GLP-1-based pipeline as largely de-risked through clinical and commercial validation from competitor programs.
Hsieh views 2026 as a critical year for laying the groundwork of Kailera’s strategy, and rates shares Outperform.
Kailera Therapeutics Price Action
KLRA Stock Price Activity: Kailera Therapeutics shares were down 9.06% at $21.19 at the time of publication on Tuesday, according to Benzinga Pro data.
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