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GPCR Stock Soars 102% on Strong Phase II Obesity Data for Aleniglipron
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Key Takeaways
Structure Therapeutics' aleniglipron hit key phase II goals with significant, dose-dependent weight loss.
Higher doses in ACCESS II produced up to 15.3% placebo-adjusted weight loss at 36 weeks.
Studies showed sustained weight reduction through 44 weeks with no efficacy plateau in the OLE study.
Shares of Structure Therapeutics (GPCR - Free Report) skyrocketed 102.5% after the company reported positive top-line data from the ACCESS clinical program of aleniglipron for the treatment of obesity and/or overweight patients with at least one weight-related co-morbidity. Aleniglipron, the most advanced candidate in GPCR’s pipeline, is an investigational, orally available GLP-1 RA, designed to address patient needs and accessibility.
The latest data readout is from the 36-week core phase IIb ACCESS study and the ongoing exploratory ACCESS II study, and interim data from the ongoing Body Composition study and the ACCESS open-label extension (OLE) study.
GPCR’s Phase II ACCESS Program Results in Detail
In the core 36-week phase IIb ACCESS study, Structure Therapeutics’ aleniglipron delivered statistically significant, dose-dependent weight loss across all active arms, with the highest 120 mg dose achieving a placebo-adjusted mean weight reduction of 11.3% (27.3 lbs), meeting the primary endpoint. The study also met all key secondary endpoints, with 86% of patients on the 120mg dose achieving at least 5% weight loss and 70% achieving at least 10% weight loss, alongside improvements in systolic blood pressure and HbA1c.
More pronounced weight-loss effects were observed in the exploratory ACCESS II study evaluating higher doses of the candidate. At 36 weeks, placebo-adjusted mean weight loss reached 15.3% (35.5 lbs) with the 240 mg dose, with all tested doses meeting statistical significance compared to placebo. Follow-up data from the ACCESS OLE study of aleniglipron further showed continued weight reduction through 44 weeks, with no evidence of an efficacy plateau, supporting the durability of the response and strengthening the rationale for advancing to phase III.
In the past year, Structure Therapeutics' shares have surged 101.7% compared with the industry’s 10.2% growth.
Image Source: Zacks Investment Research
Aleniglipron demonstrated a safety and tolerability profile consistent with the GLP-1 RA class, with gastrointestinal events being the most common adverse effects, typically occurring early in treatment. In the phase IIb ACCESS study, treatment discontinuations due to adverse events averaged 10.4% across active dose arms, with similar patterns observed at higher doses in ACCESS II. Notably, studies using a lower 2.5 mg starting dose showed improved tolerability, with no adverse event-related discontinuations reported in either the body composition or OLE studies at the 2.5 mg or subsequent 5 mg doses. Across the broader clinical program, no drug-induced liver injury, sustained liver enzyme elevations, or QTc prolongation were observed, supporting aleniglipron’s favorable safety profile as it advances toward late-stage development.
GPCR’s Next Steps in the Aleniglipron Development Plan
Based on the encouraging results from the ACCESS, ACCESS II, body composition and ACCESS OLE studies, Structure Therapeutics is currently gearing up to advance aleniglipron into phase III development.
The company intends to request a Type B end-of-phase 2 meeting with the FDA in the first half of 2026 to align on the impending phase III study design, which currently incorporates a lower 2.5 mg starting dose and plans to assess multiple dose levels up to 240 mg. Structure Therapeutics expects to initiate the phase III program of aleniglipron to treat obesity and/or overweight patients around mid-2026.
Beyond aleniglipron, Structure Therapeutics is developing ANPA-0073, a phase II-ready APJR agonist candidate designed to enable selective, muscle-sparing weight loss. GPCR is also advancing several obesity drug candidates based on different mechanisms of action at the preclinical stage, including dual amylin and calcitonin receptor agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR) and glucagon receptor agonists. The company’s pipeline also includes a promising candidate for idiopathic pulmonary fibrosis.
Structure Therapeutics Inc. Sponsored ADR Price and Consensus
Eli Lilly (LLY - Free Report) and Novo Nordisk (NVO - Free Report) dominate the obesity space with their respective obesity drugs, Zepbound (tirzepatide) and Wegovy (semaglutide). Stocks of both these key players were down on Wednesday following GPCR’s encouraging phase II obesity results.
According to research conducted by Goldman Sachs, the obesity market in the United States is expected to reach $100 billion by 2030. This is evident from the fact that LLY and NVO have not only optimized their production capacities but are also developing more potent and convenient GLP-1-based candidates in their clinical pipeline.
NVO and LLY are racing to introduce oral weight-loss pills. Novo Nordisk has already submitted a regulatory filing with the FDA seeking approval for an oral version of Wegovy, with a final decision expected soon. NVO is also developing several next-generation candidates in its obesity pipeline, including CagriSema (a combination of semaglutide and cagrilintide) and an oral pill, amycretin (a dual GLP-1 and amylin receptor agonist).
Lilly is investing broadly in obesity and has several new molecules currently in clinical development, with a range of oral and injectable medications using different mechanisms of action. This includes two late-stage candidates, orforglipron, a once-daily oral GLP-1 small molecule, and retatrutide, a GGG tri-agonist, along with some mid-stage candidates, bimagrumab, eloralintide, and mazdutide. LLY plans to file regulatory applications for orforglipron in obesity soon, setting up the timeline for a potential launch next year.
Several other companies, like Viking Therapeutics (VKTX - Free Report) , are also making rapid progress in the development of GLP-1-based candidates in their clinical pipeline.
Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. In June, VKTX started two late-stage studies evaluating the subcutaneous formulation of its investigational obesity drug, VK2735. While one of these studies recently completed enrolment at a rapid pace, VKTX expects to complete enrolment in the other study by early 2026.
Image: Bigstock
GPCR Stock Soars 102% on Strong Phase II Obesity Data for Aleniglipron
Key Takeaways
Shares of Structure Therapeutics (GPCR - Free Report) skyrocketed 102.5% after the company reported positive top-line data from the ACCESS clinical program of aleniglipron for the treatment of obesity and/or overweight patients with at least one weight-related co-morbidity. Aleniglipron, the most advanced candidate in GPCR’s pipeline, is an investigational, orally available GLP-1 RA, designed to address patient needs and accessibility.
The latest data readout is from the 36-week core phase IIb ACCESS study and the ongoing exploratory ACCESS II study, and interim data from the ongoing Body Composition study and the ACCESS open-label extension (OLE) study.
GPCR’s Phase II ACCESS Program Results in Detail
In the core 36-week phase IIb ACCESS study, Structure Therapeutics’ aleniglipron delivered statistically significant, dose-dependent weight loss across all active arms, with the highest 120 mg dose achieving a placebo-adjusted mean weight reduction of 11.3% (27.3 lbs), meeting the primary endpoint. The study also met all key secondary endpoints, with 86% of patients on the 120mg dose achieving at least 5% weight loss and 70% achieving at least 10% weight loss, alongside improvements in systolic blood pressure and HbA1c.
More pronounced weight-loss effects were observed in the exploratory ACCESS II study evaluating higher doses of the candidate. At 36 weeks, placebo-adjusted mean weight loss reached 15.3% (35.5 lbs) with the 240 mg dose, with all tested doses meeting statistical significance compared to placebo. Follow-up data from the ACCESS OLE study of aleniglipron further showed continued weight reduction through 44 weeks, with no evidence of an efficacy plateau, supporting the durability of the response and strengthening the rationale for advancing to phase III.
In the past year, Structure Therapeutics' shares have surged 101.7% compared with the industry’s 10.2% growth.
Image Source: Zacks Investment Research
Aleniglipron demonstrated a safety and tolerability profile consistent with the GLP-1 RA class, with gastrointestinal events being the most common adverse effects, typically occurring early in treatment. In the phase IIb ACCESS study, treatment discontinuations due to adverse events averaged 10.4% across active dose arms, with similar patterns observed at higher doses in ACCESS II. Notably, studies using a lower 2.5 mg starting dose showed improved tolerability, with no adverse event-related discontinuations reported in either the body composition or OLE studies at the 2.5 mg or subsequent 5 mg doses. Across the broader clinical program, no drug-induced liver injury, sustained liver enzyme elevations, or QTc prolongation were observed, supporting aleniglipron’s favorable safety profile as it advances toward late-stage development.
GPCR’s Next Steps in the Aleniglipron Development Plan
Based on the encouraging results from the ACCESS, ACCESS II, body composition and ACCESS OLE studies, Structure Therapeutics is currently gearing up to advance aleniglipron into phase III development.
The company intends to request a Type B end-of-phase 2 meeting with the FDA in the first half of 2026 to align on the impending phase III study design, which currently incorporates a lower 2.5 mg starting dose and plans to assess multiple dose levels up to 240 mg. Structure Therapeutics expects to initiate the phase III program of aleniglipron to treat obesity and/or overweight patients around mid-2026.
Beyond aleniglipron, Structure Therapeutics is developing ANPA-0073, a phase II-ready APJR agonist candidate designed to enable selective, muscle-sparing weight loss. GPCR is also advancing several obesity drug candidates based on different mechanisms of action at the preclinical stage, including dual amylin and calcitonin receptor agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR) and glucagon receptor agonists. The company’s pipeline also includes a promising candidate for idiopathic pulmonary fibrosis.
Structure Therapeutics Inc. Sponsored ADR Price and Consensus
Structure Therapeutics Inc. Sponsored ADR price-consensus-chart | Structure Therapeutics Inc. Sponsored ADR Quote
Competition Intensifies in the Obesity Space
Eli Lilly (LLY - Free Report) and Novo Nordisk (NVO - Free Report) dominate the obesity space with their respective obesity drugs, Zepbound (tirzepatide) and Wegovy (semaglutide). Stocks of both these key players were down on Wednesday following GPCR’s encouraging phase II obesity results.
According to research conducted by Goldman Sachs, the obesity market in the United States is expected to reach $100 billion by 2030. This is evident from the fact that LLY and NVO have not only optimized their production capacities but are also developing more potent and convenient GLP-1-based candidates in their clinical pipeline.
NVO and LLY are racing to introduce oral weight-loss pills. Novo Nordisk has already submitted a regulatory filing with the FDA seeking approval for an oral version of Wegovy, with a final decision expected soon. NVO is also developing several next-generation candidates in its obesity pipeline, including CagriSema (a combination of semaglutide and cagrilintide) and an oral pill, amycretin (a dual GLP-1 and amylin receptor agonist).
Lilly is investing broadly in obesity and has several new molecules currently in clinical development, with a range of oral and injectable medications using different mechanisms of action. This includes two late-stage candidates, orforglipron, a once-daily oral GLP-1 small molecule, and retatrutide, a GGG tri-agonist, along with some mid-stage candidates, bimagrumab, eloralintide, and mazdutide. LLY plans to file regulatory applications for orforglipron in obesity soon, setting up the timeline for a potential launch next year.
Several other companies, like Viking Therapeutics (VKTX - Free Report) , are also making rapid progress in the development of GLP-1-based candidates in their clinical pipeline.
Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist, VK2735, is being developed both as oral and subcutaneous formulations for the treatment of obesity. In June, VKTX started two late-stage studies evaluating the subcutaneous formulation of its investigational obesity drug, VK2735. While one of these studies recently completed enrolment at a rapid pace, VKTX expects to complete enrolment in the other study by early 2026.
GPCR’s Zacks Rank
Structure Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.