A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

Purpose

This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).

Conditions

  • Obesity
  • Overweight

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease - History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria

  • Diabetes mellitus - Change in body weight greater than 5 kg within 3 months prior to starting study - Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity - History of pancreatitis - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide (lead-in) 		Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
Tirzepatide MTD 		Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Placebo Comparator
Placebo 		Participants received weekly doses of placebo SC for 52 weeks.
  • Other: Placebo
    Administered SC

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact