Clinical trial

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

Active, not recruiting · Phase 3 · 3 countries · Registry ID NCT05869903

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight, Overweight or Obesity

Full registry criteria

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.

Treatments and study arms

Orforglipron

Drug

Administered orally.

Placebo

Drug

Administered orally.

Primary outcomes

Percent Change From Baseline in Body Weight (Primary Treatment Period)Baseline, Week 72

Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

Study locations

138 locations were listed when this page was built. The first 40 are shown.

Hospital São Domingos🇧🇷 Bequimão, Maranhão, Brazil