Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06439277




Registration number
NCT06439277
Ethics application status
Date submitted
28/05/2024
Date registered
3/06/2024
Date last updated
10/10/2024

Titles & IDs
Public title
A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Scientific title
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)
Secondary ID [1] 0 0
I8F-MC-GPIX
Secondary ID [2] 0 0
18832
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: Tirzepatide - Participants will receive tirzepatide subcutaneously (SC).

Placebo comparator: Placebo - Participants will receive placebo SC.


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
Percent Change from Baseline in Body Mass Index (BMI)
Timepoint [1] 0 0
Baseline, Week 72
Primary outcome [2] 0 0
A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity
Timepoint [2] 0 0
Baseline, Week 72
Secondary outcome [1] 0 0
Percentage of Participants Who Achieve BMI Reduction of = 5%
Timepoint [1] 0 0
Week 72
Secondary outcome [2] 0 0
Percentage of Participants Who Achieve BMI Reduction of = 10%
Timepoint [2] 0 0
Week 72
Secondary outcome [3] 0 0
Percentage of Participants Who Achieve BMI Reduction of = 15%
Timepoint [3] 0 0
Week 72
Secondary outcome [4] 0 0
Percentage of Participants Who Achieve BMI Reduction of = 20%
Timepoint [4] 0 0
Week 72
Secondary outcome [5] 0 0
Change from Baseline in Hemoglobin A1c (HbA1c)
Timepoint [5] 0 0
Baseline, Week 72
Secondary outcome [6] 0 0
Percent Change from Baseline in Triglycerides
Timepoint [6] 0 0
Baseline, Week 72
Secondary outcome [7] 0 0
Change from Baseline in Systolic Blood Pressure (SBP)
Timepoint [7] 0 0
Baseline, Week 72
Secondary outcome [8] 0 0
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)
Timepoint [8] 0 0
Baseline, Week 72
Secondary outcome [9] 0 0
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)
Timepoint [9] 0 0
Baseline, Week 72
Secondary outcome [10] 0 0
Change from Baseline in Diastolic Blood Pressure (DBP)
Timepoint [10] 0 0
Baseline, Week 72
Secondary outcome [11] 0 0
Percent Change from Baseline in Body Weight
Timepoint [11] 0 0
Baseline, Week 72
Secondary outcome [12] 0 0
Change from Baseline in Waist Circumference
Timepoint [12] 0 0
Baseline, Week 72

Eligibility
Key inclusion criteria
* Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
* Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
* Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to

* gastric bypass
* sleeve gastrectomy
* restrictive bariatric surgery, such as Lap-Band gastric banding, or
* any other procedure intended to result in weight reduction.
* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
* Have type 2 diabetes or have a HbA1c > 6.4% at screening
* 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

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Hunter Medical Research Institute - Newcastle
Recruitment hospital [2] 0 0
University of Sydney - Charles Perkins Centre - Sydney
Recruitment hospital [3] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Cornerstone Dermatology - Coorparoo
Recruitment hospital [5] 0 0
Nightingale Research - Adelaide
Recruitment hospital [6] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2006 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4151 - Coorparoo
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad Autónoma De Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Tucumán
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
France
State/province [14] 0 0
Bouches-du-Rhône
Country [15] 0 0
France
State/province [15] 0 0
Haute-Garonne
Country [16] 0 0
France
State/province [16] 0 0
Maine-et-Loire
Country [17] 0 0
France
State/province [17] 0 0
Nord-Pas-de-Calais
Country [18] 0 0
France
State/province [18] 0 0
Rhône
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
Germany
State/province [20] 0 0
Baden-Württemberg
Country [21] 0 0
Germany
State/province [21] 0 0
Nordrhein-Westfalen
Country [22] 0 0
Germany
State/province [22] 0 0
Sachsen
Country [23] 0 0
Israel
State/province [23] 0 0
HaDarom
Country [24] 0 0
Israel
State/province [24] 0 0
HaMerkaz
Country [25] 0 0
Israel
State/province [25] 0 0
HaTsafon
Country [26] 0 0
Israel
State/province [26] 0 0
Yerushalayim
Country [27] 0 0
Israel
State/province [27] 0 0
?eifa
Country [28] 0 0
Mexico
State/province [28] 0 0
Jalisco
Country [29] 0 0
Mexico
State/province [29] 0 0
Nuevo León
Country [30] 0 0
Mexico
State/province [30] 0 0
Aguascalientes
Country [31] 0 0
Mexico
State/province [31] 0 0
Puebla
Country [32] 0 0
Puerto Rico
State/province [32] 0 0
San Juan
Country [33] 0 0
Spain
State/province [33] 0 0
Andalucía
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona [Barcelona]
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid, Comunidad De
Country [36] 0 0
Spain
State/province [36] 0 0
Málaga
Country [37] 0 0
Spain
State/province [37] 0 0
València
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taichung
Country [39] 0 0
Taiwan
State/province [39] 0 0
Tainan
Country [40] 0 0
Taiwan
State/province [40] 0 0
Taipei
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taoyuan
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Cambridgeshire
Country [43] 0 0
United Kingdom
State/province [43] 0 0
England
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Hampshire
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London, City Of
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Leeds
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Liverpool
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Sheffield

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

Ethics approval
Ethics application status

Summary
Brief summary
The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.
Trial website
https://clinicaltrials.gov/study/NCT06439277
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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06439277