A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

Résumé

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Percent body weight loss

   Percent change from baseline to Week 72 in body weight

   Délai 72 weeks

2. Critère de jugement secondaire

   Absolute body weight loss

   Absolute change from baseline to Week 72 in body weight (kg)

   Délai 72 weeks

3. Critère de jugement secondaire

   Total body weight loss of at least 5%, 10%, and 15%

   * Achieved ≥ 5% body weight loss from baseline at Week 72 * Achieved ≥ 10% body weight loss from baseline at Week 72 * Achieved ≥ 15% body weight loss from baseline at Week 72

   Délai 72 weeks

4. Critère de jugement secondaire

   Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline

   Percent change from baseline to Week 72 in body weight

   Délai 72 weeks

5. Critère de jugement secondaire

   Waist circumference reduction

   Absolute change from baseline to Week 72 in waist circumference (cm)

   Délai 72 weeks

6. Critère de jugement secondaire

   Glycemic control

   Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%)

   Délai 72 weeks

7. Critère de jugement secondaire

   Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline

   Achieved normoglycemia (HbA1c \< 5.7% \[39 mmol/mol\]) at Week 72

   Délai 72 weeks

8. Critère de jugement secondaire

   Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline

   * Achieved HbA1c \< 7.0% (53 mmol/mol) at Week 72 * Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72

   Délai 72 weeks

9. Critère de jugement secondaire

   Systolic blood pressure reduction

   Change from baseline to Week 72 in systolic blood pressure (mmHg)

   Délai 72 weeks

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

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Documents de l'étude

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Évolution au fil du temps

1. 9 septembre 2026

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