Roche to report Phase 2 enicepatide data in obesity with type 2 diabetes at Sept. 28 Pharma Day
New mid-stage data would show whether Roche's dual GLP-1/GIP drug works as well in people who also have type 2 diabetes as it did in people with obesity alone, though no Roche obesity drug is approved.
Roche is expected to report Phase 2 results for its experimental obesity drug enicepatide in people who have both obesity and type 2 diabetes, with the study listed as completing Sept. 24 and a company Pharma Day scheduled for Sept. 28 [1]. Analysts at William Blair expect that event to cover the readout along with updates on three other Roche obesity programs [1].
Enicepatide, also known as CT-388, is a once-weekly injectable that acts on both the GLP-1 and GIP hormones — the same two targets hit by Eli Lilly's tirzepatide, sold as Mounjaro and Zepbound [1][2]. Roche acquired the drug as a Phase 2-ready asset through its January 2024 purchase of Carmot Therapeutics [2].
The company has already reported results from a separate Phase 2 study in people with obesity but not type 2 diabetes. At a 24 mg once-weekly dose, the drug produced placebo-adjusted weight loss of 22.5% at 48 weeks, and participants' weight was still falling at that point rather than leveling off, Roche said in January [1][2]. In that study, 95.7% of participants on the 24 mg dose lost at least 5% of their body weight, 87% lost at least 10%, 47.8% lost at least 20% and 26.1% lost at least 30%. Just over half — 54% — dropped below a BMI of 30, compared with 13% on placebo. Among participants who started the trial with prediabetes, 73% returned to normal blood glucose levels, compared with 7.5% on placebo [2].
Most side effects were mild to moderate gastrointestinal problems, which are common for this drug class, and 5.9% of participants in the CT-388 arms stopped treatment because of adverse events, compared with 1.3% on placebo [2]. Full results were slated for presentation at an upcoming medical congress [2].
Whether the drug performs the same way in people who also have type 2 diabetes has not been reported. That is the question the newer study, designated CT388-104, was designed to answer, and its results have not been disclosed [2].
Roche has no approved obesity medicine and sits behind market leaders Eli Lilly and Novo Nordisk [1]. Teresa Graham, chief executive of Roche's pharmaceutical division, said in January that the company aims to become a "top three player" in obesity [1]. Roche has described enicepatide as a potential best-in-class asset and dropped a different candidate, acmopatide, earlier this year [1].
Beyond enicepatide, the Sept. 28 event is expected to include updates on the once-daily oral drug CT-996, on the antibody emugrobart given in combination with Zepbound, and on petrelintide, a once-weekly amylin injection being developed with partner Zealand Pharma. Roche has said Phase 3 trials of CT-996 and petrelintide are planned to start in 2026 [1].
Why it matters for patients
None of the Roche drugs discussed here is approved for use, and all remain in mid- or late-stage testing [1]. That means the Sept. 24 study completion and the Sept. 28 Pharma Day are steps in research, not the arrival of a new treatment option.
The results will matter most for people who have both obesity and type 2 diabetes, a group studied separately from the participants in the first Phase 2 trial [2]. Data from that first trial do not show how the drug performs in that group, and no results from the obesity-plus-diabetes study have been released.
Obesity medicines generated $66 billion in sales last year and could reach between $105 billion and $200 billion by 2027 and beyond, according to IQVIA [1]. More competition generally means more choices across mechanisms, doses and formats — including a daily pill rather than a weekly injection — though whether any specific pipeline drug is safer, more effective or cheaper than what is already on the market has not been established.
Separately, a temporary Medicare program that began granting improved access to obesity medications in July could grow coverage by an estimated 35%, reaching around 20 million potential patients, according to William Blair [1]. That program applies to medications already on the market, not to the Roche candidates.
What happens next
Sept. 24 is the listed completion date for the Phase 2 study of enicepatide in people with obesity and type 2 diabetes [1]. Roche's Pharma Day follows on Sept. 28, where the company is expected to discuss those outcomes and its other mid-stage obesity trials [1].
Roche said in January that its Phase 3 program for the drug, called Enith1 and Enith2, was expected to start that quarter [2]. Whether those trials are running on that timeline has not been disclosed. Phase 3 starts for CT-996 and petrelintide are planned for 2026 [1].
Sources
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