The ENITH 1 Study

Status:

Sponsor: F. Hoffman-LaRoche

Trial Summary


This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).

The main results measured in the study to assess if the medicine has worked are change in body weight and change in blood sugar levels (known as ‘HbA1c’) after about 11 months of study treatment.

Other key results measured in the study include:

  • Change in body weight after about 6 months
  • Changes in blood sugar during the study, and how many participants have certain levels at specific times
  • The number of participants with blood sugar below 7% with at least 5% weight loss, or blood sugar at or below 6.5% with at least 10% weight loss, at 6 and 11 months
  • Change in body weight, BMI and waist and hip measurements after 11 months
  • Changes in blood markers for how the body processes sugar

Condition(s) being studied:​

Overweight or Obese, Type 2 Diabetes Mellitus (T2DM)

Age range

≥18 Years & ≤ 75 Years

Trial date:

Primary Completion (Actual)

2026-05-29

Study Completion (Estimated)

2026-09-24

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