Roche’s acquired GLP-1/GIP receptor agonist, enicepatide, normalised blood sugar and reduced weight in patients with type 2 diabetes and overweight or obesity in a Phase II trial.
In the CT-388-104 study (NCT06628362), enicepatide met both primary endpoints, delivering dose-dependent and clinically meaningful reductions in blood glucose and body weight after 48 weeks of treatment.
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Patients receiving the highest titrated dose of 24mg achieved an HbA1c reduction of 2.65%, with 90% of patients in the cohort reaching an HbA1c level of ≤6.5%, the diagnostic threshold for type 2 diabetes. In contrast, 62% achieved normoglycaemia, restoring blood glucose levels to a non-diabetic range.
The mean weight loss at 48 weeks in the high dose arm was 15.5% without a demonstrable plateau.
The safety and tolerability profile of enicepatide was consistent with other established incretin-based therapies, with the most common adverse events (AEs) being gastrointestinal effects. The randomised, double-blind, placebo-controlled, CT-388-104 study enrolled 447 adults with type 2 diabetes and obesity.
Roche’s CMO and head of global product development, Dr Levi Garraway, said: “We are highly encouraged by the efficacy demonstrated by enicepatide in this Phase II study, including the meaningful proportion of patients reaching normalised glucose levels within less than a year of treatment. Combined with sustained weight loss, enicepatide offers a potential best-in-disease profile capable of reducing and preventing complications as well as enhancing metabolic health for people living with type 2 diabetes.”
Roche acquired Carmot Therapeutics for $2.7bn in 2024, with the deal including three obesity and diabetes assets, CT-388 – now called enicepatide, CT-996 and CT-868. CT-868 was dropped from Roche’s pipeline in July 2026 due to “strategic portfolio slimming”. CT-996 is in a Phase II trial (NCT07081958) in patients with obesity or overweight, both with and without type 2 diabetes.
Enicepatide, a once-weekly subcutaneous injectable, dual-acting GLP-1/GIP receptor agonist, has already advanced to late-stage in obesity, with two ongoing Phase III studies in chronic weight management (ENITH-1 and ENITH-2). Roche plans to initiate a Phase III glycaemic-control programme and cardiovascular trials in H1 2027.
In January 2026, Roche announced data from a separate Phase II trial in which the 24mg dose of enicepatide led to weight loss of 22.5% after 48 weeks in patients with obesity who do not have type 2 diabetes.
Obesity and diabetes markets are highly competitive
This data drops while the competition in the obesity and type 2 diabetes markets grows.
The main pair in the ring are Eli Lilly and Novo, who continue to butt heads, even more so since Novo has filed a lawsuit against its main competitor after alleged misleading and false advertising campaigns.
Both Lilly and Novo are also fighting for dominance in the oral weight loss space, with both companies having marketed their first oral obesity drugs in 2026. Novo has gained a first-to-market advantage in the US, Europe and the UK, which are some of the key regions for these therapies.
Other major pharma companies are hoping to access the lucrative market, including Pfizer, AstraZeneca and Amgen.
GlobalData’s report, “GLP-1 Innovation Landscape 2026: Industry Insights,” reveals that the use of GLP-1RA drugs is rapidly expanding beyond treatments for diabetes and into mainstream weight management because they are effective at increasing satiety and reducing food intake, resulting in rapid weight loss.
Use among patients without diabetes but with overweight or obesity in the US rose 700% from 2019 to 2023, according to researchers from the University of Pennsylvania and Cedars-Sinai Medical Center.
While injectables remain the growth engine through 2031, the convenience and affordability of the GLP‑1RA pill format is expected to expand the user base, with pill market sales expected to rise from $3.2bn in 2025 to $34.3bn in 2031, according to GlobalData’s Pharmaceutical Intelligence Centre.
GlobalData is the parent company of Clinical Trials Arena.
