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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05556512




Registration number
NCT05556512
Ethics application status
Date submitted
22/09/2022
Date registered
27/09/2022
Date last updated
1/10/2024

Titles & IDs
Public title
A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity
Secondary ID [1] 0 0
I8F-MC-GPIJ
Secondary ID [2] 0 0
17253
Universal Trial Number (UTN)
Trial acronym
SURMOUNT-MMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Overweight 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide
Treatment: Drugs - Placebo

Experimental: Tirzepatide - Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.

Placebo comparator: Placebo - Participants will receive tirzepatide matched placebo.


Treatment: Drugs: Tirzepatide
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)
Timepoint [1] 0 0
Up to 5 Years
Secondary outcome [1] 0 0
Time to Onset of Type 2 Diabetes (T2D)
Timepoint [1] 0 0
Up to 5 Years
Secondary outcome [2] 0 0
Estimated Glomerular Filtration Rate (eGFR) Slope
Timepoint [2] 0 0
Up to 5 Years
Secondary outcome [3] 0 0
Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)
Timepoint [3] 0 0
Up to 5 Years
Secondary outcome [4] 0 0
Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score
Timepoint [4] 0 0
Baseline, 2 Years
Secondary outcome [5] 0 0
Time to the Occurrence of All-cause Death
Timepoint [5] 0 0
Up to 5 Years
Secondary outcome [6] 0 0
Time to First Occurrence of CV Death
Timepoint [6] 0 0
Up to 5 Years
Secondary outcome [7] 0 0
Time to First Occurrence of MI
Timepoint [7] 0 0
Up to 5 Years
Secondary outcome [8] 0 0
Time to First Occurrence of Stroke
Timepoint [8] 0 0
Up to 5 Years
Secondary outcome [9] 0 0
Time to First Occurrence of Coronary Revascularization
Timepoint [9] 0 0
Up to 5 Years
Secondary outcome [10] 0 0
Time to First Occurrence Heart Failure (HF) Events
Timepoint [10] 0 0
Up to 5 Years
Secondary outcome [11] 0 0
Time to First Occurrence of Hospitalization for Unstable Angina
Timepoint [11] 0 0
Up to 5 Years
Secondary outcome [12] 0 0
Time to first occurrence of Hospitalization or Urgent Visit
Timepoint [12] 0 0
Up to 5 Years
Secondary outcome [13] 0 0
Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death)
Timepoint [13] 0 0
Up to 5 Years
Secondary outcome [14] 0 0
Percent Change from Baseline in Body Weight
Timepoint [14] 0 0
Baseline, 156 Weeks
Secondary outcome [15] 0 0
Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)
Timepoint [15] 0 0
Baseline, 156 Weeks
Secondary outcome [16] 0 0
Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)
Timepoint [16] 0 0
Baseline, 156 Weeks
Secondary outcome [17] 0 0
Percentage of Participants with Hemoglobin A1c (HbA1c) <39 Millimole/Mole (mmol/mol) (5.7%)
Timepoint [17] 0 0
Up to 5 Years

Eligibility
Key inclusion criteria
* Have a body mass index (BMI) =27.0 kilogram/square meter (kg/m ²)
* Are either

* individuals =40 years of age with established cardiovascular disease (CVD).

* CVD is defined as meeting at least one of the following:

* Coronary artery disease
* Cerebrovascular disease
* Peripheral arterial disease OR
* individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention)
* women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or

* women =70 years of age or men, =65 years of age with at least 2 risk factors at screening.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma
* Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c =6.5% (=48 millimole/mole (mmol/mol) or fasting glucose (FG) =126 milligram/deciliter (=7.0 millimole/liter (mmol/L).
* Any one of the following CV conditions within 90 days prior to screening

* MI
* acute coronary syndrome
* stroke
* coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or
* acute decompensated heart failure
* Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
* Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening
* Have a presence or history of malignant neoplasms within the past 5 years prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/10/2027
Actual
Sample size
Target
Accrual to date
Final
15374
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [4] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [5] 0 0
University of Sydney - Charles Perkins Centre - Sydney
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
Core Research Group - Brisbane
Recruitment hospital [8] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [9] 0 0
Nightingale Research - Adelaide
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [12] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [13] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [14] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [15] 0 0
Emeritus Research - Camberwell
Recruitment hospital [16] 0 0
Victorian Heart Hospital - Clayton
Recruitment hospital [17] 0 0
Barwon Health - Geelong
Recruitment hospital [18] 0 0
Austin Health - Repatriation Hospital - Heidelberg West
Recruitment hospital [19] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne - Melbourne
Recruitment hospital [20] 0 0
Advara HeartCare Joondalup - Joondalup
Recruitment hospital [21] 0 0
GenesisCare - Murdoch - Murdoch Drive - Murdoch
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2291 - Merewether
Recruitment postcode(s) [5] 0 0
2006 - Sydney
Recruitment postcode(s) [6] 0 0
4029 - Brisbane
Recruitment postcode(s) [7] 0 0
4064 - Brisbane
Recruitment postcode(s) [8] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [11] 0 0
5011 - Woodville
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3124 - Camberwell
Recruitment postcode(s) [15] 0 0
3168 - Clayton
Recruitment postcode(s) [16] 0 0
3220 - Geelong
Recruitment postcode(s) [17] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [18] 0 0
3004 - Melbourne
Recruitment postcode(s) [19] 0 0
6027 - Joondalup
Recruitment postcode(s) [20] 0 0
6150 - Murdoch
Recruitment outside Australia
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Rotherham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.
Trial website
https://clinicaltrials.gov/study/NCT05556512
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05556512