A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (SURMOUNT-4)

May 21, 2024 updated by: Eli Lilly and Company

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
783

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1419AHN
        • Asociación de Beneficencia Hospital Sirio Libanés
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1120AAC
        • Centro Medico Viamonte
      • Caba, Buenos Aires, Argentina, C1060ABN
        • CEDIC
      • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, C1023AAB
        • STAT Research S.A.
    • Ciudad Autónoma De Buenos Aire
      • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1128AAF
        • Mautalen Salud e Investigación
      • Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, Argentina, C1425AGC
        • Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto Médico Catamarca IMEC
  • Brazil
      • Rio de Janeiro, Brazil, 22241-180
        • IBPClin - Instituto Brasil de Pesquisa Clínica
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055450
        • CEDOES
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-480
        • Cline Research Center
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
        • Nucleo de Pesquisa Clínica do Rio Grande do Sul
    • São Paulo
      • Campinas, São Paulo, Brazil, 13034-685
        • Centro de Pesquisa São Lucas
      • Sao Paulo, São Paulo, Brazil, 03325-050
        • BR Trials - Ensaios Clinicos e Consultoria
      • São José dos Campos, São Paulo, Brazil, 12243-280
        • ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
  • Puerto Rico
      • Bayamon, Puerto Rico, 00959
        • Centro de Endocrinologia Alcantara Gonzalez
      • San Juan, Puerto Rico, 00921
        • Private Practice Dr. Martha Gomez Cuellar
      • Vega Baja, Puerto Rico, 00694
        • Wellness clinical Research Vega Baja
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng-Kung Uni. Hosp.
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
  • United States
    • Alabama
      • Pelham, Alabama, United States, 35124
        • Cahaba Research
    • California
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital La Jolla
      • Los Angeles, California, United States, 90057
        • National Research Institute - Wilshire
      • Panorama City, California, United States, 91402
        • National Research Institute
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
    • Colorado
      • Golden, Colorado, United States, 80401
        • New West Physicians Clinical Research
      • Monument, Colorado, United States, 80132
        • Optumcare Colorado Springs - Monument
    • Florida
      • Jacksonville, Florida, United States, 32277
        • Care Partners Clinical Research
      • Margate, Florida, United States, 33063
        • South Florida Clinical Research Institute
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Tampa, Florida, United States, 33613
        • ForCare Clinical Research
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
      • Union City, Georgia, United States, 30291
        • SKY Clinical Research Network Group-Blake
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research
    • Illinois
      • Flossmoor, Illinois, United States, 60422
        • Healthcare Research Network - Chicago
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute for Clinical Research
      • New Albany, Indiana, United States, 47150
        • American Health Network of Indiana, LLC - New Albany
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute (MedStar Physician Based Research Network)
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices and Research
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Research Institute - Endocrinology
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Medical Center
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center (WFUBMC)
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Aventiv Research Inc
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Capital Area Research, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
    • Texas
      • Bellaire, Texas, United States, 77401
        • The University of Texas Health Science Center at Houston
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • North Richland Hills, Texas, United States, 76180
        • North Hills Family Medicine/North Hills Medical Research
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • Tomball, Texas, United States, 77375
        • Northwest Houston Heart Center
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
    • Washington
      • Olympia, Washington, United States, 98502
        • Capital Clinical Research Center
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Randomization in Body Weight at Week 88
Time Frame: Randomization (Week 36), Week 88
Least square (LS) mean was analysed by mixed model repeated measures (MMRM) model with randomization + analysis country + sex + interactive web response system (IWRS) MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Randomization in Body Weight at Week 64
Time Frame: Randomization (Week 36), Week 64
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 64
Change From Randomization in Body Weight
Time Frame: Randomization (Week 36), Week 88
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
Change From Randomization in Waist Circumference
Time Frame: Randomization (Week 36), Week 88
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
Change From Randomization in Body Mass Index (BMI)
Time Frame: Randomization (Week 36), Week 88
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
Change From Randomization in Fasting Glucose
Time Frame: Randomization (Week 36), Week 88
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
Change From Randomization in Hemoglobin A1c (HbA1c)
Time Frame: Randomization (Week 36), Week 88
LS mean was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
Percent Change From Randomization in Fasting Insulin
Time Frame: Randomization (Week 36), Week 88
LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
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))
Time Frame: Randomization (Week 36), Week 88
LS mean was analysed by MMRM model with log(actual measurement/randomization) = log (randomization) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
Change From Randomization in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)
Time Frame: Randomization (Week 36), Week 88
LS mean change was analysed by MMRM model with randomization + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Randomization (Week 36), Week 88
Change From Randomization in Short Form 36 Version 2 Health Survey (SF 36v2) Acute Form - Physical Functioning Domain Score
Time Frame: Randomization (Week 36), Week 88

The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.

LS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables.
Randomization (Week 36), Week 88
Change From Randomization in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Function Composite Score
Time Frame: Randomization (Week 36), Week 88

The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better health-related quality of life.

LS mean was analysed by ANCOVA model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables.
Randomization (Week 36), Week 88
Percentage of Participants Who Maintain at Least 80% of the Body Weight Lost During the Open-Label Lead-In Period
Time Frame: Week 88
Percentage of Participants Who Maintain at least 80% of the Body Weight Lost During the Open-Label Lead-In Period was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment*Time as variables.
Week 88
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction From Baseline
Time Frame: Baseline (Week 0) to Week 88
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, ≥20% Body Weight Reduction from baseline was analysed by Logistic regression model with missing value imputed by MMRM at week 88. Missing values were imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures with Baseline + Analysis Country + Sex + IWRS MTD at Week 36 + randomization + Treatment + Time + Treatment*Time as variables.
Baseline (Week 0) to Week 88
Time to First Occurrence of Participants Returning to >95% Baseline Weight for Those Who Lost ≥5% During the Open-Label Lead-In Period
Time Frame: Randomization (Week 36) to Week 88
Time to first occurrence of participants returning to >95% baseline weight for those who lost ≥5% during the open-label lead-in period.
Randomization (Week 36) to Week 88
Change From Baseline in BMI
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + BMI at randomization (kg/m^2) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Change From Baseline in Body Weight
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Percent Change From Baseline in Body Weight
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + body weight at randomization (kg) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Change From Baseline in Waist Circumference
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Change From Baseline in Fasting Glucose
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Change From Baseline in HbA1c
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Percent Change From Baseline in Fasting Insulin
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with log(actual measurement/baseline) = log (baseline) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Percent Change From Baseline in Lipid Parameters (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides, FFAs)
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with log(actual measurement/baseline) = log (baseline) + analysis country + sex + IWRS MTD at Week 36 + weight loss at week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Change From Baseline in SBP, DBP
Time Frame: Baseline (Week 0), Week 88
LS mean was analysed by MMRM model with baseline + analysis country + sex + IWRS MTD at Week 36 + Weight Loss at Week 36 (< 10%, >= 10%) + treatment + time + treatment*time (Type III sum of squares) as variables.
Baseline (Week 0), Week 88
Change From Baseline in SF 36v2 Acute Form - Physical Functioning Domain Score
Time Frame: Baseline (Week 0), Week 88

The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.

LS mean was analysed by analysis of covariance (ANCOVA) model with randomization + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables.
Baseline (Week 0), Week 88
Change From Baseline in IWQOL-Lite-CT - Physical Function Composite Score
Time Frame: Baseline (Week 0), Week 88

The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better health-related quality of life.

LS mean was analysed by ANCOVA model with baseline + analysis Country + sex + weight loss at Week 36 (< 10%, >= 10%) + IWRS MTD at Week 36 + treatment (type III sum of squares) as variables.
Baseline (Week 0), Week 88

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17247
  • I8F-MC-GPHN (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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