A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Overweight or Obesity; Overweight; Obesity

Treatments: Drug: Placebo; Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT05869903

2022-502839-19-00 (Other Identifier)

J2A-MC-GZGP (Other Identifier)

U1111-1289-8877 (Other Identifier)

18559

Details and patient eligibility

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,000 participants in 4 patient groups, including a placebo group

Orforglipron Dose 1

Experimental group

Description:

Participant will receive orforglipron administered orally.

Treatment:

Drug: Orforglipron

Orforglipron Dose 2

Experimental group

Description:

Participant will receive orforglipron administered orally.

Treatment:

Drug: Orforglipron

Orforglipron Dose 3

Experimental group

Description:

Participant will receive orforglipron administered orally.

Treatment:

Drug: Orforglipron

Placebo

Placebo Comparator group

Description:

Participants will be given placebo.

Treatment:

Drug: Placebo