Active — Not RecruitingPhase 3

A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

United States3,127 participantsStarted 2023-06-05

Plain-language summary

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Have a BMI * ≥30.0 kilogram/square meter (kg/m²), * ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening: * Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure). * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: * Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma * Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening. * Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome. * Have had a history of chronic or acute pancreatitis.

What they're measuring

Mean Percent Change from Baseline in Body Weight

Timeframe: Baseline to Week 72

Trial details

NCT IDNCT05869903

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-25

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