On Thursday, Eli Lilly and Co. (NYSE:LLY) reported positive topline results from its Phase 3 ACHIEVE-4 trial of its oral drug Foundayo (orforglipron) for weight loss.
The study showed that orforglipron met the primary goal of cardiovascular safety compared with insulin glargine in adults with type 2 diabetes and obesity or overweight at elevated cardiovascular risk.
The study also indicated stronger reductions in blood sugar and body weight, positioning the therapy as a potential alternative to insulin-based treatment.
Foundayo Meets Cardiovascular Safety Goal
The ACHIEVE-4 trial, the largest and longest study of Foundayo in type 2 diabetes so far, enrolled more than 2,700 participants across 15 countries.
The drug demonstrated a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke, and hospitalization for unstable chest pain, compared with insulin glargine.
The risk of these events was 16% lower with Foundayo, with a hazard ratio of 0.84, meeting predefined criteria for non-inferiority.
Superior A1C And Weight Reduction
Foundayo delivered stronger efficacy outcomes. Patients treated with the drug showed greater improvements in A1C levels and body weight at 52 weeks compared to insulin glargine, with benefits sustained through 104 weeks.
The trial also showed a 57% lower risk of all-cause death for patients taking Foundayo, with a hazard ratio of 0.43 and nominal statistical significance.
Additionally, the therapy improved several cardiovascular risk markers, including non-HDL cholesterol, systolic blood pressure, triglycerides, and hsCRP levels.
Safety Profile Aligns With GLP-1 Class
The overall safety and tolerability profile of Foundayo was consistent with prior studies and the broader GLP-1 drug class.
During the minimum 52-week treatment period, 10.6% of patients discontinued therapy due to adverse events.
A detailed analysis of potential drug-induced liver injury (DILI) found no hepatic safety concerns.
Lilly said it plans to submit Foundayo for approval in type 2 diabetes to the U.S. Food and Drug Administration by the end of the second quarter, utilizing the Commissioner’s National Priority Review Voucher pathway.
Clinical Trials Deemed Necessary For Eli Lilly
The U.S. Food and Drug Administration (FDA) requested additional data from Eli Lilly following signals of potential liver injury linked to Foundayo.
In a letter posted by the FDA, the agency stated that only clinical trials—not observational or nonclinical studies—would adequately evaluate risks associated with the drug.
These include concerns around drug-induced liver injury (DILI) and exposure during lactation.
The regulator also pointed to a potential issue involving retained gastric contents, which could elevate the risk of pulmonary aspiration.
To address this, the FDA has directed the company to conduct a clinical pharmacology study using ultrasound to examine how fasting duration and temporary discontinuation of the drug affect gastric emptying.
LLY Stock Price Activity: Eli Lilly shares were up 0.77% at $912 during premarket trading on Thursday, according to Benzinga Pro data.
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