Boehringer Initiates Phase III Obesity Trials, Seeks to Challenge Novo and Lilly

External view of Boehringer Ingelheim's headquarters in Silicon Valley

External view of Boehringer Ingelheim’s headquarters in Silicon Valley

The German company on Thursday said it is launching three late-stage studies of its obesity drug candidate after the injectable showed up to 19% weight loss after 46 weeks in a mid-stage trial.

Pictured: Boehringer Ingelheim sign on a building/iStock, Sundry Photography

Boehringer Ingelheim is looking to challenge Novo Nordisk and Eli Lilly in the lucrative obesity market, advancing its weight-loss injectable into pivotal studies. The company announced Thursday it will initiate three Phase III trials for its glucagon/GLP-1 receptor dual agonist with patient enrollment planned before the end of the year.

In a Phase II trial, overweight or obese participants on survodutide saw close to 19% weight loss after 46 weeks of treatment. Weight reduction had not plateaued at the 46-week mark, suggesting additional weight loss could occur with longer treatment, the company said.

Up to 40% of participants who reached the highest two doses achieved a weight loss of at least 20%, suggesting survodutide to be at least as effective if not more than the competition.

For the moment, Novo Nordisk’s Wegovy stands alone in its approval to treat obesity. Patients on Wegovy reported an average weight reduction of just under 10% in people with overweight or obesity and Type 2 diabetes (T2D).

Lilly’s Mounjaro seems more effective. A clinical trial comparing Lilly’s T2D drug head-to-head with Wegovy for weight loss is under way, to be completed by December 2024. A Phase III trial of Mounjaro compared to placebo resulted in 15.7% body weight reduction for those on the highest dose after about 18 months. Just under a third of participants reported a 20% weight loss.

An FDA nod for an obesity indication for Lilly is anticipated by the end of 2023.

With an estimate that 2.7 billion adults will be overweight or obese by 2025, the potential for weight-loss drugs like Novo’s, Lilly’s and Boehringer’s is massive. Morgan Stanley analysts predict the global obesity drug market to reach $50 billion by 2030.

Oral formulations are also underway. Novo Nordisk is testing an oral formulation of semaglutide. A once-daily dose of 50 mg resulted in weight loss of just over 15% compared to placebo in overweight or obese adults without T2D.

Pfizer is also working on an oral weight-loss drug, danuglipron. Phase II study results show a similar weight loss to Novo Nordisk’s injectable.

Survodutide was co-invented by Boehringer and Zealand Pharma. The injection is also in a Phase II study for adults with nonalcoholic steatohepatitis (NASH) and liver fibrosis, with or without T2D.

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

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