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Enicepatide Phase II Results: 15.5% Weight Loss and Strong HbA1c Reductions at 48 Weeks
In Roche’s 447 patient Phase II diabetes study, weekly 24 mg enicepatide led to 15.5% mean weight loss and a 2.65 percentage point HbA1c reduction from an 8.1% baseline at 48 weeks, with no observed weight loss plateau. Among people starting with HbA1c above 8.5%, the mean reduction was 4.13 percentage points; 90% r...
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Research answer
Key takeaways
- In Roche’s 447 patient Phase II diabetes study, weekly 24 mg enicepatide led to 15.5% mean weight loss and a 2.65 percentage point HbA1c reduction from an 8.1% baseline at 48 weeks, with no observed weight loss plateau.
- Among people starting with HbA1c above 8.5%, the mean reduction was 4.13 percentage points; 90% reached HbA1c ≤6.5% and 62% reached HbA1c <5.7%.
- Adverse event discontinuation was 2.0% across enicepatide arms versus 0% with placebo.
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openai.comCreate a landscape editorial hero image for this Studio Global article: What were the efficacy, safety, and next-step findings from Roche’s 447-patient Phase II trial of weekly 24 mg enicepatide in people with ty. Article summary: Roche’s Phase II results make enicepatide a credible late-entry contender in obesity and type 2 diabetes, with unusually large glucose reductions and strong weight loss. But it remains an indirect, early-stage comparison. Topic tags: general, news, general web, government. Style: premium digital editorial illustration, source-backed research mood, clean composition, high detail, modern web publication hero. Use reference image context only for broad subject, composition, and topical grounding; do not copy the exact image. Avoid: logos, brand marks, copyrighted characters, real person likenesses, fake screenshots, UI text, readable text, watermarks, charts with
Roche’s Phase II CT-388-104 trial gives enicepatide a notable early efficacy signal in adults with type 2 diabetes and overweight or obesity. At the highest, 24 mg once-weekly dose, participants had substantial reductions in both body weight and HbA1c after 48 weeks. However, these are mid-stage, company-reported results—not a direct comparison with an approved rival—and longer, larger trials will determine whether the profile holds up. 2
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The key 48-week efficacy findings
The randomized, double-blind, placebo-controlled Phase II trial enrolled 447 adults with type 2 diabetes and overweight or obesity. 5 Roche reported that the 24 mg weekly dose met the study’s two primary endpoints, with dose-dependent reductions in body weight and blood glucose.
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At 48 weeks, the 24 mg group showed:
- 15.5% mean body-weight loss from baseline. Roche said the weight-loss trajectory had not plateaued at week 48.
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- A 2.65-percentage-point mean HbA1c reduction from a mean baseline HbA1c of 8.1%.
- A 4.13-percentage-point mean HbA1c reduction among participants with baseline HbA1c above 8.5%, the subgroup with poorer glycemic control at entry.
- 90% reaching HbA1c ≤6.5%, a threshold Roche described as its type 2 diabetes glycemic target.
- 62% reaching HbA1c <5.7%, which Roche defined as normoglycemia.
The HbA1c findings are especially attention-grabbing because the reductions were large in the higher-baseline-HbA1c subgroup. Still, subgroup results should be confirmed in larger trials designed to assess consistency across different patient populations.
Safety: low discontinuation, but limited detail so far
Roche characterized enicepatide’s safety and tolerability profile as consistent with the incretin class. The most common adverse events were predominantly mild-to-moderate gastrointestinal effects, and Roche reported no new safety signals. 20
Discontinuations due to adverse events occurred in 2.0% of participants across enicepatide treatment arms, compared with 0.0% in the placebo arm. 20
The topline announcement does not provide event-specific rates for nausea, vomiting, diarrhea, constipation, or other gastrointestinal effects. That means the available information cannot yet support a reliable numerical tolerability comparison with other incretin medicines. Longer follow-up and fuller trial disclosures will be important for assessing uncommon and longer-term safety outcomes.
How the diabetes result compares with Roche’s earlier obesity study
Roche previously reported results from a separate Phase II study of enicepatide in people with overweight or obesity without type 2 diabetes. In that study, the highest dose produced 22.7% mean weight loss at 48 weeks, and more than one-quarter of participants receiving the highest dose lost at least 30% of body weight. Roche also reported no sign of a weight-loss plateau at week 48. 1
The 15.5% result in the diabetes study is therefore 7.2 percentage points lower than the 22.7% reported in the earlier non-diabetes study. That arithmetic difference should not be read as a controlled treatment comparison: the trials enrolled different populations and were run separately. What can be said is that Roche reported no 48-week plateau in either study, leaving open—without proving—the possibility of further weight loss with longer treatment. 1
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What the results do—and do not—say versus Mounjaro
Enicepatide and Eli Lilly’s tirzepatide, marketed as Mounjaro for type 2 diabetes, are both once-weekly medicines that target GIP and GLP-1 pathways. Tirzepatide has a substantially more mature evidence base, including regulatory-reviewed trials and approved-product experience. In one EMA-reviewed trial, tirzepatide 15 mg reduced HbA1c by 2.15 percentage points at week 40 under the efficacy estimand. 30
Roche’s 2.65-percentage-point reduction with enicepatide at week 48 is numerically larger, but it does not establish superiority over tirzepatide. The trials differ in study populations, baseline characteristics, treatment duration, titration, controls, and analytic methods. No head-to-head enicepatide-versus-tirzepatide trial has been reported in the provided evidence. 2
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The practical takeaway is more measured: enicepatide has produced an efficacy signal that makes it a serious emerging competitor in the obesity and diabetes pipeline. It has not yet demonstrated comparative superiority, long-term safety, or cardiovascular benefit.
What Roche plans next
Roche has said it has two Phase III chronic-weight-management trials under way, ENITH-1 and ENITH-2. It also plans to begin a Phase III glycemic-control program and cardiovascular-outcomes trials in the first half of 2027. 2
Those next studies will need to answer the questions that a 48-week Phase II trial cannot settle:
- Does weight loss and glucose control remain durable with longer treatment?
- Are the results reproducible in larger and more diverse populations?
- How does enicepatide compare directly with established therapies on efficacy and gastrointestinal tolerability?
- Does treatment improve cardiovascular outcomes?
- Does the safety profile remain favorable with broader exposure and longer follow-up?
Bottom line
At 24 mg weekly, enicepatide delivered 15.5% mean weight loss and a 2.65-percentage-point HbA1c reduction over 48 weeks in Roche’s Phase II trial in type 2 diabetes, while the reported weight-loss curve had not plateaued. 2 The low reported adverse-event discontinuation rate is encouraging, but detailed gastrointestinal-event data and long-term safety data are still limited. Phase III programs—not cross-trial comparisons—will determine whether the early results translate into a durable, differentiated option in an increasingly competitive incretin market.
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What is the short answer to "Enicepatide Phase II Results: 15.5% Weight Loss and Strong HbA1c Reductions at 48 Weeks"?
In Roche’s 447 patient Phase II diabetes study, weekly 24 mg enicepatide led to 15.5% mean weight loss and a 2.65 percentage point HbA1c reduction from an 8.1% baseline at 48 weeks, with no observed weight loss plateau.
What are the key points to validate first?
In Roche’s 447 patient Phase II diabetes study, weekly 24 mg enicepatide led to 15.5% mean weight loss and a 2.65 percentage point HbA1c reduction from an 8.1% baseline at 48 weeks, with no observed weight loss plateau. Among people starting with HbA1c above 8.5%, the mean reduction was 4.13 percentage points; 90% reached HbA1c ≤6.5% and 62% reached HbA1c <5.7%.
What should I do next in practice?
Adverse event discontinuation was 2.0% across enicepatide arms versus 0% with placebo.