October 1, 2026

Foundayo ACHIEVE-4 Heart Data, Survodutide SYNCHRONIZE-2 in NEJM, CVS Caremark Restores Zepbound Coverage

Foundayo meets its heart-safety goal against insulin glargine, survodutide dropouts weigh on Zealand, and CVS Caremark's Zepbound coverage returns.

5 stories · Covering clinical-trials, industry

Editor's Note

EASD's fourth day brought two trials that met their goals and still left questions. ACHIEVE-4 showed Lilly's daily pill Foundayo was no worse than insulin glargine on heart events in 2,749 people with type 2 diabetes; the lower death rate Lilly highlighted came from an exploratory analysis. Boehringer's survodutide reached up to 13.1% weight loss in SYNCHRONIZE-2, but 18% of patients stopped because of gastrointestinal side effects, and Zealand's shares fell 11.7%. Kailera finished enrolling about 4,900 people in its ribupatide Phase 3 program, which includes a head-to-head comparison with semaglutide. In the U.S., CVS Caremark's restored Zepbound coverage took effect, and outside the GLP-1 class, BioMarin and Ascendis finalized the license that ends their fight over the CNP prodrug Yuviwel.

Clinical Trials

Lilly's Foundayo Meets Cardiovascular Noninferiority Goal Against Insulin Glargine in Phase 3 ACHIEVE-4, Published in The Lancet

Lilly presented the Phase 3 ACHIEVE-4 trial of its oral small-molecule GLP-1 drug Foundayo (orforglipron) at EASD on Thursday, October 1, 2026, alongside publication in The Lancet. In 2,749 adults with type 2 diabetes, overweight or obesity, and increased cardiovascular risk, Foundayo met its noninferiority goal against insulin glargine for cardiovascular death, heart attack, stroke, or hospitalization for unstable angina (MACE-4 hazard ratio 0.84; 95% CI 0.59 to 1.20); the three-part MACE-3 hazard ratio was 0.77 (95% CI 0.52 to 1.13). At 52 weeks, A1C fell 1.6 points versus 1.0 and weight fell 8.8% versus a 1.7% gain on glargine. Lilly also reported a lower rate of death from any cause (hazard ratio 0.43) but described that analysis as exploratory and not controlled for multiple comparisons; 10.6% of Foundayo patients stopped treatment because of adverse events.

#foundayo #orforglipron #cardiovascular #eli-lilly #easd-2026

Clinical Trials

Boehringer's Survodutide Hits Both Endpoints in Phase 3 SYNCHRONIZE-2 With Up to 13.1% Weight Loss, but 18% Stop for GI Side Effects

Boehringer Ingelheim and partner Zealand Pharma reported on Thursday, October 1, 2026 that the Phase 3 SYNCHRONIZE-2 trial of survodutide, a weekly glucagon/GLP-1 receptor dual agonist, met its co-primary endpoints in 755 adults with obesity or overweight and type 2 diabetes; the results were presented at EASD and published in the New England Journal of Medicine. At 76 weeks, under the efficacy estimand, weight fell up to 13.1% on survodutide (3.6 mg and 6.0 mg doses were tested) versus 3.1% on placebo, and HbA1c fell up to 1.21 points from a baseline of 7.4% versus 0.03. Eighteen percent of survodutide patients stopped treatment because of gastrointestinal side effects, versus 1.2% on placebo, and Zealand's shares fell 11.7% in Copenhagen, according to Investing.com.

#survodutide #boehringer-ingelheim #zealand-pharma #type-2-diabetes #easd-2026

Industry

CVS Caremark's Return of Zepbound as a Preferred Weight-Loss Drug Takes Effect October 1

CVS Caremark's addition of Lilly's Zepbound back to its commercial template formularies as an additional preferred weight-loss option takes effect on Thursday, October 1, 2026, the date the pharmacy benefit manager set when it announced the reversal on May 28. NBC News reported that about 25 million to 30 million people are covered under Caremark's standard formulary, which had excluded Zepbound in favor of Novo's Wegovy since 2025. Plan sponsors that use the templates can still customize coverage, so whether a given patient's plan covers Zepbound depends on the employer.

#cvs-caremark #zepbound #insurance-coverage #eli-lilly

Clinical Trials

Kailera Completes Enrollment of About 4,900 People in Ribupatide's Phase 3 KaiNETIC Program, Including a Head-to-Head Against Semaglutide

Kailera Therapeutics said on Wednesday, September 30, 2026 that it has finished enrolling about 4,900 adults in the three-trial KaiNETIC Phase 3 program for ribupatide, a weekly GLP-1/GIP dual agonist licensed from Hengrui, including KaiNETIC-3, which compares ribupatide with semaglutide 2.4 mg in about 1,200 people with a BMI of 35 or higher. Each trial runs 76 weeks with titration up to 10 mg, and topline results are expected in mid-2028. At EASD on October 1, Kailera reported a 51-person Phase 1 study in which ribupatide exposure after injection in the upper arm or thigh was similar to abdominal injection, and early Phase 1 data for the triple agonist HRS-4729 showing 16.0% mean weight loss at week 12 on 12 mg in 10 participants.

#kailera #ribupatide #hengrui #obesity

Industry

BioMarin and Ascendis Sign Final License Ending Patent Fight Over CNP Prodrug Yuviwel, With Royalties of 20% in the U.S. Through May 2030

BioMarin disclosed in a September 30, 2026 SEC filing that it signed a final settlement and license agreement with Ascendis Pharma on September 24, effective retroactively to August 28, turning the companies' August 31 term sheet into a definitive deal over Yuviwel (navepegritide), Ascendis's once-weekly prodrug of C-type natriuretic peptide (CNP). The license covers navepegritide products for all indications, including achondroplasia, for which the FDA approved Yuviwel in children 2 and older in February 2026, and hypochondroplasia. Ascendis will pay royalties of 20% of U.S. net sales and 18% in the European Union, Brazil, and South Korea from first commercial sale until May 2030, and the companies will dismiss all pending patent litigation with prejudice.

#ascendis-pharma #biomarin #yuviwel #litigation