A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)

Lilly

Status and phase: Invitation-only; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06584916

J2A-MC-GZPN (Other Identifier)

27239

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.

Full description

All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed the SURMOUNT-5 study on study treatment

Exclusion criteria

• Have Type 1 Diabetes, Type 2 Diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
• Have a prior or planned surgical treatment for obesity
• Have acute or chronic hepatitis
• Have a history of acute or chronic pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Orforglipron

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo