A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06047548

18720

I8F-MC-GPIQ (Other Identifier)

Details and patient eligibility

About

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

Full description

All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:

  • Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease

• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)

Exclusion criteria

• Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.

• Have a self-reported change in BW>5 kilogram (kg) within 3 months prior to screening

• Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed >1 year prior to screening.

• Have a history of chronic or acute pancreatitis

• Have any of the following cardiovascular conditions within 3 months prior to week 0.

  • Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF)
  • family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

• History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years

• Any lifetime history of a suicide attempt

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 3 patient groups, including a placebo group

Tirzepatide 5 milligram (mg)

Experimental group

Description:

Participants will receive tirzepatide subcutaneously (SC).

Treatment:

Drug: Tirzepatide

Tirzepatide Maximum Tolerated Dose

Experimental group

Description:

Participants will receive tirzepatide SC.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo