Structure Therapeutics reported results from a mid-stage clinical trial showing that its oral obesity treatment aleniglipron produced significant weight reduction compared with placebo after 44 weeks of treatment. The company announced the findings on as developers continue efforts to enter the competitive market for weight-loss medications, which is currently led by injectable therapies.
In the phase 2 trial, known as Access II, the San Francisco-based biotechnology company evaluated daily doses of aleniglipron in 85 adults who were overweight or living with obesity. Participants began treatment at a starting dose of 5 mg and were gradually increased over four weeks to target doses of 120 mg, 180 mg, or 240 mg.
At 44 weeks, the three dosing groups recorded mean weight reductions of 13.6%, 15.3%, and 15%, respectively. When adjusted for placebo, these results corresponded to weight loss of 14.7%, 16.3%, and 16%. The highest placebo-adjusted reduction was observed in the 180 mg group.
Structure has described the 16% weight loss—equivalent to about 39 pounds—as the strongest result reported to date for an oral GLP-1 therapy, and the company is preparing the drug candidate for phase 3 testing. Analysts had previously estimated that weight loss approaching 16% could make the treatment competitive with other oral options in development.
Earlier data had shown that a 240 mg dose produced weight loss of up to 15.3% after 36 weeks of treatment. According to Guggenheim analyst Seamus Fernandez, the new findings indicate continued progress over time. Fernandez stated that the 44-week results showed the ability to reach leading levels of weight reduction across all dose levels and that there was no clear sign that weight loss had begun to level off.
Fernandez also said tolerability outcomes were an important aspect of the data. “Most critical was the extended tolerability now through median 20 weeks of treatment that appears highly competitive on vomiting and discontinuations while maintaining strong and consistent weight loss,” he said.
Structure reported that the safety profile of aleniglipron was consistent with other drugs in the GLP-1 class. Gastrointestinal side effects were the most frequently reported adverse events, with nausea and vomiting most commonly occurring during the dose-escalation phase of treatment.
The company noted that only one treatment discontinuation related to adverse events occurred among participants receiving doses of 120 mg or higher between weeks 28 and 44 in the Access II study.
Additional information came from other ongoing research programs. Interim results from another study suggested that beginning treatment with a lower starting dose of 2.5 mg instead of 5 mg reduced the number of patients who stopped treatment due to side effects. In a separate body composition study involving 71 participants, the lower starting dose was associated with improvements in discontinuation rates linked to adverse events.
An open-label extension of the earlier Access trial also provided updated findings. In that extension, patients receiving the 120 mg dose experienced weight loss of up to 16.2% after 56 weeks of treatment. The study reported an overall adverse-event-related discontinuation rate of 2% among participants who had a median follow-up period of 20 weeks.
Investor reaction to the latest data was modest. Structure’s shares rose during trading following the announcement, reaching $56.10 by 10 a.m. ET compared with a closing price of $53.75 the previous Friday.
The company plans to meet with the U.S. Food and Drug Administration during the second quarter to discuss the development program. Structure expects to begin a phase 3 clinical trial for aleniglipron in the second half of the year.
Aleniglipron’s Efficacy in Weight Reduction
The Phase 2 study showed that Aleniglipron significantly reduced body weight in participants compared to placebo. These results highlight Aleniglipron as a promising option for patients seeking effective oral obesity treatments.
How Aleniglipron Works
Aleniglipron is designed to regulate metabolic pathways that influence appetite and energy balance. By targeting these mechanisms, Aleniglipron helps patients achieve sustainable weight loss with a convenient oral dosing regimen.
Safety Profile of Aleniglipron
The study also confirmed that Aleniglipron was generally well tolerated. Most adverse effects were mild to moderate, supporting Aleniglipron’s suitability for broader clinical development.
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