Roche said it would step on the gas pedal to catch up to Novo Nordisk and Eli Lilly (plus many other hopefuls) in obesity.
And it has.
The Swiss pharma conglomerate has kicked off a Phase 2 trial of the GLP-1/GIP agonist from its $2.7 billion Carmot Therapeutics acquisition, according to an update this week on the US federal trials database. The move comes quickly on the heels of unveiling more Phase 1b data for the experimental drug, dubbed CT-388, that sent Roche’s shares trending up. At the time of the July 15 data drop, the company said it would begin a mid-stage test of the asset later this year.
According to the new trial entry, Roche was estimated to begin the 450-patient study on July 29, with a primary completion slated for January 2026. The study is testing five dosages of the once-weekly CT-388, which is delivered under the skin. At 48 weeks, trial investigators will assess the percent change in body weight from baseline and compare it to a placebo cohort. A Roche spokesperson declined to add further details, such as the trial’s dosing regimen.
Jefferies analysts have said the experimental medicine “looks competitive,” given it appeared to have not yet plateaued in weight reduction at the 24-week mark in the Phase 1b trial. The analysts estimate $4 billion in peak sales, which assumes a 2029 launch and significant investments in Phase 3.
Key secondary outcomes include how many trial participants lose more than 5%, 10%, 15%, 20% or 25% of their body weight from the time they entered the study. They’ll also assess differences in body mass index, waist and hip circumference, HbA1c levels, fasting glucose, fasting insulin, suicide severity rating scale and other measurements.
Thomas SchineckerRoche also has an oral obesity candidate, named CT-996, and shared Phase 1 data earlier this month. Beyond CT-388 and that asset, Carmot could give Roche five additional shots on goal in obesity, CEO Thomas Schinecker recently told the Financial Times. And it might buy more. On a quarterly earnings call last week, Schinecker hinted at the potential for further deals.
“I can’t comment on anything that we’re looking at currently,” Schinecker said on the July 25 earnings call. “In terms of the kind of deals, I think what we did last year [with Carmot] could be something that you could imagine also for this year.”
It will have to invest heavily to compete with many other pharmaceutical and biotech companies that are attempting to carve a lane in Novo and Lilly’s backyard. AstraZeneca, Amgen, Pfizer, Boehringer Ingelheim, Regeneron and multiple other companies are all vying for a spot.