Eli Lilly and Company Presents Results for Foundayo and Zepbound in Weight Loss Maintenance Trials

Eli Lilly and Company announced detailed results from two late-phase trials showing that people with obesity maintained their weight loss long term with either Foundayo or lower-dose Zepbound after switching from higher doses of injectable incretin therapy. The findings from SURMOUNT-MAINTAIN and ATTAIN-MAINTAIN, were presented at the 33rd European Congress on Obesity (ECO) and published in The Lancet and Nature Medicine, respectively. In SURMOUNT-MAINTAIN, both Zepbound MTD and Zepbound 5 mg met the primary and all key secondary endpoints, demonstrating weight-loss maintenance after 60-weeks of initial treatment with Zepbound MTD.

The primary endpoint was to demonstrate that continuation of Zepbound either at a reduced 5 mg dose or at MTD was superior to placebo in percent change in body weight at week 112. At week 112, participants continuing treatment with Zepbound MTD preserved all of their prior weight loss, while dose reduction to 5 mg maintained all but 5.6 kg on average. ATTAIN-MAINTAIN demonstrated that switching to Foundayo also supported long-term weight maintenance, meeting the primary and all key secondary endpoints using both the efficacy estimand and treatment-regimen estimand.

The primary endpoint was to demonstrate that Foundayo was superior to placebo in percent maintenance of body weight reduction, among SURMOUNT-5 participants who previously reached a body weight plateau. At week 52, participants who switched from Wegovy MTD to Foundayo maintained all but 0.9 kg of their previously achieved weight loss, while those who switched from Zepbound MTD to Foundayo maintained all but 5.0 kg. Across both trials, Foundayo and Zepbound demonstrated safety profiles consistent with prior Phase 3 studies.

In ATTAIN-MAINTAIN, the most common adverse events with Foundayo vs. placebo were nausea (18.8% vs. 4.1%), constipation (13.1% vs.

4.1%), vomiting (8.3% vs. 3.4%) or diarrhea (7.4% vs. 7.5%).

Discontinuation rates due to adverse events for patients randomized to placebo or Foundayo were 4.8% (Foundayo from Wegovy), 7.6% (placebo from Wegovy), 7.2% (Foundayo from Zepbound) and 6.3% (placebo from Zepbound). In SURMOUNT-MAINTAIN, the most common adverse events during the maintenance period with Zepbound MTD and Zepbound 5 mg vs. placebo were diarrhea (7.2% and 4.9% vs.

1.1%), vomiting (6.5% and 0.7% vs. 0%) and nausea (5.8% and 4.2% vs. 2.2%).

Discontinuation rates due to adverse events during the maintenance period with Zepbound MTD, Zepbound 5 mg and placebo were 0%, 0.7% and 0%, respectively. Zepbound (tirzepatide) is a once-weekly dual GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist. Zepbound is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones.

Both GIP and GLP-1 receptors are found in areas of the human brain important for appetite regulation. Zepbound decreases calorie intake, and the effects are likely mediated by affecting appetite. Studies of tirzepatide in chronic kidney disease (CKD) and in morbidity/mortality in obesity (MMO) are ongoing.Tirzepatide has been approved by the U.S. FDA as Mounjaro for adults with type 2 diabetes to improve glycemic control, and as Zepbound for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off.

Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Tirzepatide is also approved as Mounjaro in some countries outside the U.S. for adults with type 2 diabetes, obesity or those who are overweight who also have a weight-related comorbid condition. Both Mounjaro and Zepbound should be used in combination with diet and exercise.