The trial is taking place at:
O

Oviedo Medical Research | Oviedo, FL

Veeva-enabled site

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

Lilly logo

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

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

Trial contacts and locations

20

Loading...

Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems