Roche: Reports Positive Phase II Results For Dual GLP-1/GIP Agonist Enicepatide In Type 2 Diabetes And Overweight Or Obesity

Roche reported positive topline Phase II data for enicepatide in adults with T2D and overweight/obesity, showing a 2.65% HbA1c reduction from 8.1% and 15.5% mean weight loss at 48 weeks on 24 mg, with safety consistent with incretin therapies.Material DetailsContext by AI AnalystThis is mid-stage v…

Roche reported positive topline Phase II results for enicepatide, a once-weekly dual GLP-1/GIP agonist, in type 2 diabetes. The trial showed clinically meaningful improvements in blood sugar control, with many patients reaching diabetes targets or normal-range glucose levels. Participants also recorded sustained weight loss over the study period, supporting enicepatide’s positioning in cardiometabolic disease. Safety broadly matched the incretin class, with mostly mild-to-moderate gastrointestinal effects and low treatment discontinuations. Roche is running two Phase III weight-management studies, with Phase III diabetes and cardiovascular outcomes programs planned for 1H 2027. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Roche Holding AG published the original content used to generate this news brief via (Ref. ID: 202609220100OMX_____CNEWS_EN_GNW1001273913_en) on September 22, 2026, and is solely responsible for the information contained therein. (C)

For best results when printing this announcement, please click on link below: Genentech Announces Positive Phase II Results for Dual GLP-1/GIP Receptor Agonist Enicepatide in People Living With Type 2 Diabetes and Overweight or Obesity ● At the highest dose (24 mg), enicepatide achieved a mean HbA1c reduction of 2.65% at 48 weeks, highlighting its potential for best-in-disease glycemic control ● In patients with poor baseline glycemic control (HbA1c >8.5%), enicepatide 24 mg led to an HbA1c reduction of 4.13% at 48 weeks ● By week 48, 90% of patients in the 24 mg enicepatide arm met the T2D glycemic target of ≤6.5% HbA1c, while 62% achieved normoglycemia (HbA1c < 5.7%) ● At the highest 24 mg dose, enicepatide achieved a mean weight loss of 15.5% at 48 weeks, without a weight loss plateau ● Enicepatide demonstrated a safety and tolerability profile consistent with the incretin class, with low discontinuation rates and no new safety signals identified Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), today announced positive topline results from CT-388-104, a Phase II clinical trial evaluating enicepatide (CT-388), an investigational, once-weekly dual GLP-1/GIP receptor agonist, in adults living with type 2 diabetes (T2D) and overweight or obesity. In the study, enicepatide met both primary endpoints, delivering dose-dependent and clinically meaningful reductions in blood glucose and body weight at 48 weeks. Patients receiving the highest titrated dose (24 mg) achieved an HbA1c reduction of 2.65% (from a baseline HbA1c of 8.1%). Furthermore, 90% of patients in the 24 mg cohort reached an HbA1c level of ≤6.5% (diagnostic threshold for T2D) and 62% achieved normoglycemia (HbA1c < 5.7%), restoring blood glucose levels to a non-diabetic range. The mean weight loss at 48 weeks in the 24 mg enicepatide 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 being predominantly mild-to-moderate gastrointestinal effects. In addition, the treatment discontinuation rate due to adverse events was low (2.0% in enicepatide arms; 0.0% in placebo arm). The totality of data positions enicepatide, a unique dually biased GLP-1/GIP receptor agonist, as a differentiated molecule designed for potentially greater efficacy with a favorable safety profile. “We are highly encouraged by the efficacy demonstrated by enicepatide in this Phase II study, including the meaningful proportion of patients reaching normalized glucose levels within less than a year of treatment,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “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.” Genentech is advancing a broad late-s

Genentech reported positive Phase II results for enicepatide, a once-weekly dual GLP-1/GIP agonist in adults with type 2 diabetes. At 48 weeks, the 24 mg dose cut HbA1c by 2.65% from an 8.1% baseline. Mean weight loss reached 15.5% at 48 weeks, with no plateau observed. Discontinuations due to adverse events were 2% across enicepatide arms, versus 0% on placebo. Genentech is running Phase III weight-management studies ENITH-1 and ENITH-2, targeting Phase III glycemic trials and CV outcomes studies in 1H 2027. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Roche Holding AG published the original content used to generate this news brief via (Ref. ID: 20260921428313) on September 22, 2026, and is solely responsible for the information contained therein. (C)