A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants with Obesity or Overweight with or without Type 2 Diabetes Mellitus (Embold)

Conditions

Participants Living with Obesity or Overweight with at least 1 comorbidity with or without Type 2 Diabetes Mellitus

Brief summary

Percent change from baseline to Week 72 in body weight

Detailed description

Absolute change from baseline to Week 72 in body weight, 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, Percent change from baseline to Week 72 in body weight in participants with BMI ≥ 27 kg/m2 at baseline, Absolute change from baseline to Week 72 in waist circumference (cm), Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%), Achieved normoglycemia (HbA1c < 5.7% [39 mmol/mol]) at Week 72 in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline Study 2 only: • Achieved HbA1c < 7.0% (53 mmol/mol) at Week 72 in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline Study 2 only: • Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72 in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline, Change from baseline to Week 72 in systolic blood pressure (mmHg)

Related papers

No related papers found yet.

Interventions

DRUGElecoglipron

DRUGPlacebo for Elecoglipron (AZD5004)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline to Week 72 in body weight	—

Secondary

Measure	Time frame
Absolute change from baseline to Week 72 in body weight, 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, Percent change from baseline to Week 72 in body weight in participants with BMI ≥ 27 kg/m2 at baseline, Absolute change from baseline to Week 72 in waist circumference (cm), Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%), Achieved normoglycemia (HbA1c < 5.7% [39 mmol/mol]) at Week 72 in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline Study 2 only: • Achieved HbA1c < 7.0% (53 mmol/mol) at Week 72 in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline Study 2 only: • Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72 in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline, Change from baseline to Week 72 in systolic blood pressure (mmHg)	—

Measure

Time frame

Absolute change from baseline to Week 72 in body weight, 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, Percent change from baseline to Week 72 in body weight in participants with BMI ≥ 27 kg/m2 at baseline, Absolute change from baseline to Week 72 in waist circumference (cm), Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%), Achieved normoglycemia (HbA1c < 5.7% [39 mmol/mol]) at Week 72 in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline Study 2 only: • Achieved HbA1c < 7.0% (53 mmol/mol) at Week 72 in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline Study 2 only: • Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72 in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline, Change from baseline to Week 72 in systolic blood pressure (mmHg)

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Outcome results

None listed