Phase 3 N=783 Randomized Double-blind Treatment

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

Obesity · Overweight

Bottom Line

View on ClinicalTrials.gov: NCT04660643 ↗

Enrolled (actual)

783

Serious AEs

2.5%

Results posted

May 2024

Primary outcome: Primary: Percent Change From Randomization in Body Weight at Week 88 — 14.8; -6.7 percent change — p=<.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tirzepatide (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Randomization in Body Weight at Week 88	14.8; -6.7	<.001 sig
SECONDARY Percent Change From Randomization in Body Weight at Week 64	9.9; -6.0	<.001 sig
SECONDARY Change From Randomization in Body Weight	11.9; -5.7	<.001 sig
SECONDARY Change From Randomization in Waist Circumference	8.3; -4.6	<.001 sig
SECONDARY Change From Randomization in Body Mass Index (BMI)	4.3; -2.1	<.001 sig
SECONDARY Change From Randomization in Fasting Glucose	7.74; -0.90	<.001 sig
SECONDARY Change From Randomization in Hemoglobin A1c (HbA1c)	0.25; -0.08	<.001 sig
SECONDARY Percent Change From Randomization in Fasting Insulin	23.3; -15.4	<.001 sig
SECONDARY Percent Change From Randomization in Lipid Parameters (Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Very Low Density Lipoprotein (VLDL) Cholesterol, Triglycerides, Free Fatty Acids (FFA))	8.30; 2.29; 3.43; -3.36; 14.6; 18.3	<.001 sig
SECONDARY Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)	8.4; 2.1; 3.2; -0.4	<.001 sig
SECONDARY Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score	-1.8; 0.8	<.001 sig
SECONDARY Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score	-5.0; 4.4	<0.001 sig
SECONDARY Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period	13.50; 93.37	<0.001 sig
SECONDARY Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline	69.00; 98.49; 44.38; 93.98; 24.01; 87.05	<0.001 sig
SECONDARY Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period	NA; NA	<.001 sig
SECONDARY Change From Baseline in BMI	-3.6; -10.0	<.001 sig
SECONDARY Change From Baseline in Body Weight	-10.0; -27.6	<.001 sig
SECONDARY Percent Change From Baseline in Body Weight	-9.5; -26.0	<.001 sig
SECONDARY Change From Baseline in Waist Circumference	-9.1; -22.8	<.001 sig
SECONDARY Change From Baseline in Fasting Glucose	-1.72; -10.63	<.001 sig
SECONDARY Change From Baseline in HbA1c	-0.22; -0.57	<.001 sig
SECONDARY Percent Change From Baseline in Fasting Insulin	-29.8; -54.1	<.001 sig
SECONDARY Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs)	2.16; -5.01; 2.62; -5.21; 9.44; 12.29	<.001 sig
SECONDARY Change From Baseline in SBP, DBP	-2.4; -9.3; -1.7; -5.5	<.001 sig
SECONDARY Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score	3.7; 6.3	<.001 sig
SECONDARY Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score	16.7; 26.0	<.001 sig

Summary

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04660643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.