Roche's experimental weekly injection enicepatide lowered blood sugar and body weight in adults with type 2 diabetes and overweight or obesity over 48 weeks, the company said Tuesday. But Roche did not release specific results for the placebo group, BioSpace reported, which makes it impossible to judge how much of the improvement came from the drug itself.
At the highest dose, 24 mg, patients' HbA1c, a measure of average blood sugar over the past two to three months, fell by 2.65 percentage points from a starting average of 8.1%. Their weight fell by an average of 15.5%, according to Roche.
For the millions of Americans living with type 2 diabetes, and the caregivers who help manage it, the results are early news about a drug that is years from pharmacies. Enicepatide is not approved, and these topline figures come from a company announcement rather than a peer-reviewed publication.
Results Roche Reported, and the Number It Left Out
The CT-388-104 trial was a randomized, double-blind, placebo-controlled phase 2 study of 447 adults, according to Roche's announcement. The drug met both main goals, producing dose-dependent reductions in HbA1c and body weight at 48 weeks.
In the 24 mg group, 90% of patients reached an HbA1c of 6.5% or lower, and 62% reached below 5.7%, the range considered normal blood sugar. Patients who started with poorly controlled diabetes, an HbA1c above 8.5%, saw an average drop of 4.13 percentage points. Roche said weight loss had not leveled off by week 48.
The missing placebo numbers matter. People in diabetes trials often improve somewhat on placebo because they receive closer monitoring, diet advice, and continued background medication. Without that comparison, readers cannot calculate the drug's true added effect.
Side effects were mostly mild to moderate gastrointestinal symptoms, consistent with drugs in the same class. About 2.0% of patients across the enicepatide groups stopped treatment because of side effects, compared with none on placebo.
"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," said Dr. Levi Garraway, Roche's chief medical officer and head of global product development.
Limits of an Early Mid-Stage Readout
A phase 2 trial is designed to test doses and look for early signs that a drug works and is reasonably safe. It is typically smaller and shorter than the phase 3 trials that regulators rely on for approval. The study, registered as NCT06628362, has not yet been published in a journal, so outside researchers have not reviewed the full data, including dropout rates and results for each dose.
The findings do not show that enicepatide reverses diabetes, prevents complications, or works better than existing treatments. Reaching a normal HbA1c while on medication is not the same as remission without treatment. Longer and larger trials are needed to measure heart, kidney, and other outcomes, as well as rare side effects.
Enicepatide works on two hormone receptors, GLP-1 and GIP, the same general approach as some drugs already on the market. Roche says its version is designed to limit the way receptors become less responsive over time, a claim that phase 3 trials will need to test. MedicalDaily is not comparing its results with approved drugs, because the trials used different designs and patients.
For context, an HbA1c of 6.5% or higher is the threshold for diagnosing diabetes, while 5.7% to 6.4% is the prediabetes range. Diabetes affects nearly 600 million adults worldwide, and type 2 accounts for about 90% of cases, according to Roche.
A Long Road Before Patients Could Use It
Roche acquired the drug through its $2.7 billion purchase of Carmot Therapeutics in 2023. It is running two phase 3 trials in weight management, ENITH-1 and ENITH-2, and plans to begin phase 3 studies in blood sugar control and cardiovascular outcomes in the first half of 2027.
Earlier phase 2 results in people with obesity or overweight but without type 2 diabetes were presented at the American Diabetes Association meeting earlier this year, according to a Roche release. In that study, the highest dose produced average weight loss of 22.7% at 48 weeks, according to a BMO Capital Markets note cited by BioSpace. Roche is also testing enicepatide with petrelintide, an experimental amylin-based drug developed with partner Zealand Pharma. People with diabetes typically lose less weight on these drugs than people without it, which is one reason results from separate trials should not be compared directly.
That timeline means approval, if it comes, is likely several years away. Cost and insurance coverage for any future drug are unknown.
People with type 2 diabetes should not change or stop current medications based on these results. Several FDA-approved treatments, including metformin, GLP-1 drugs, and SGLT2 inhibitors, are available now, and a clinician can help weigh options, costs, and coverage. Anyone interested in trials can ask a doctor or search ClinicalTrials.gov for studies nearby.
Full peer-reviewed data, including placebo results, will be the next key test. Roche has not said when it will release them, and MedicalDaily will report those numbers when they become public.
Key Questions Answered
What did Roche announce? Its experimental drug enicepatide lowered HbA1c by 2.65 percentage points and weight by 15.5% at the highest dose over 48 weeks in adults with type 2 diabetes.
Why do the missing placebo results matter? Without them, it is not possible to tell how much of the improvement came from the drug rather than from trial participation.
Is enicepatide available? No. It is experimental and still needs phase 3 trials and FDA review.
What side effects were reported? Mostly mild to moderate stomach and digestive effects. About 2% of patients on the drug stopped because of side effects.
Has the study been peer reviewed? Not yet. The results come from a company announcement.
Should I change my diabetes treatment? No. Talk with your clinician about approved options, and do not stop current medications based on early trial news.
