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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 type 2 diabetes—including 48 week weight loss, HbA1c reductions from an 8.1% baseline and among those with poorest glycemic control, rates rea
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 with Lilly’s established tirzepatide/Mounjaro program; no head to head trial has been reported.
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Key takeaways
- 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 with Lilly’s established tirzepatide/Mounjaro program; no head to head trial has been reported.
- [8] CT 388 104 Phase II: efficacy at 24 mg weekly In the 447 patient study of adults with type 2 diabetes and overweight or obesity, enicepatide 24 mg produced mean weight loss of 15.5% at week 48; the weight loss curve had not demonstrably
- [8] Mean HbA1c fell 2.65 percentage points from an 8.1% baseline at week 48.
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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.. Topic tags: general web, regulation, marketing, manufacturing, finance. 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 fake numbers, clickbait thumbna
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 with Lilly’s established tirzepatide/Mounjaro program; no head-to-head trial has been reported. 8
CT-388-104 Phase II: efficacy at 24 mg weekly
- In the 447-patient study of adults with type 2 diabetes and overweight or obesity, enicepatide 24 mg produced mean weight loss of 15.5% at week 48; the weight-loss curve had not demonstrably plateaued.
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- Mean HbA1c fell 2.65 percentage points from an 8.1% baseline at week 48.
- In the subgroup with poorer baseline glycemic control (HbA1c >8.5%), the mean HbA1c reduction was 4.13 percentage points.
- At week 48, 90% of people on 24 mg reached HbA1c ≤6.5%, the stated diagnostic threshold for type 2 diabetes, and 62% reached normoglycemia, defined as HbA1c <5.7%.
Safety and tolerability
- Roche reported adverse-event discontinuations of 2.0% across enicepatide arms, versus 0% with placebo.
- The common adverse effects were predominantly mild-to-moderate gastrointestinal events, consistent with the incretin-drug class; Roche reported no new safety signals.
- The topline release does not provide event-specific rates for nausea, vomiting, diarrhea, or constipation, so a quantitative comparison of gastrointestinal tolerability with rivals is not yet possible. Insufficient evidence.
Context versus Roche’s earlier non-diabetes study
- In Roche’s earlier Phase II trial in people with overweight or obesity without diabetes, the 24 mg dose achieved 22.7% weight loss at 48 weeks, with more than one-quarter of participants reaching at least 30% loss.
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- Thus, the 15.5% result in type 2 diabetes is about 7.2 percentage points lower, but that pattern is not surprising: weight reduction with incretin therapies is generally less pronounced in populations with diabetes than in non-diabetes obesity trials. The studies were separate and should not be interpreted as a controlled comparison.
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- Both Roche studies reported no plateau at 48 weeks, supporting—but not proving—the possibility of additional loss with longer treatment.
Comparison with Mounjaro and obesity-drug rivals
- Mounjaro (tirzepatide), like enicepatide, is a once-weekly dual GIP/GLP-1 agonist and has already demonstrated significant HbA1c and weight reductions across large controlled trials and an established regulatory evidence base.
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- In an EMA-reviewed trial, tirzepatide 15 mg reduced HbA1c by 2.15 percentage points at week 40 under the efficacy estimand; Roche’s 2.65-point decline at week 48 is numerically larger, but cross-trial comparisons are unreliable because the populations, baseline characteristics, estimands, controls, titration, and follow-up differ.
- Enicepatide’s 15.5% 48-week diabetes-associated weight loss is commercially competitive-looking, while the 22.7% result in Roche’s non-diabetes study places it near the leading edge of reported Phase II obesity efficacy.
- Roche therefore has a potentially differentiated efficacy signal against Lilly and Novo Nordisk, particularly in poorly controlled diabetes, but it still trails them in pivotal-trial maturity, approved-product experience, long-term safety exposure, manufacturing scale, and outcomes evidence.
Development implications
- Roche already has two Phase III chronic-weight-management trials under way, ENITH-1 and ENITH-2.
- It plans to begin a Phase III glycemic-control program and cardiovascular-outcomes trials in the first half of 2027.
- The Phase II data support testing whether the large HbA1c reduction, high normoglycemia rate, sustained weight loss, and low discontinuation rate persist in larger and longer studies. The key remaining questions are durability, comparative efficacy and tolerability, cardiovascular benefit, and safety in broader real-world diabetes populations.
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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.
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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 with Lilly’s established tirzepatide/Mounjaro program; no head to head trial has been reported.
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[8] CT 388 104 Phase II: efficacy at 24 mg weekly In the 447 patient study of adults with type 2 diabetes and overweight or obesity, enicepatide 24 mg produced mean weight loss of 15.5% at week 48; the weight loss curve had not demonstrably