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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05260021




Registration number
NCT05260021
Ethics application status
Date submitted
25/02/2022
Date registered
2/03/2022

Titles & IDs
Public title
A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both
Secondary ID [1] 0 0
I8F-MC-GPGV
Secondary ID [2] 0 0
17121
Universal Trial Number (UTN)
Trial acronym
SURPASS-PEDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type2 Diabetes 0 0
Diabetes Mellitus 0 0
Diabetes Mellitus, Type 2 0 0
T2D 0 0
T2DM (Type 2 Diabetes Mellitus) 0 0
Glucose Metabolism Disorders 0 0
Endocrine System Diseases 0 0
Metabolic Disease 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide Dose 1
Treatment: Drugs - Tirzepatide Dose 2
Treatment: Drugs - Placebo

Experimental: Tirzepatide Dose 1 - Double-Blind:

Participants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.

Open-Label:

Participants will continue to receive Tirzepatide at the last dose level

Experimental: Tirzepatide Dose 2 - Double-Blind:

Participants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached.

Open-Label:

Participants will continue to receive Tirzepatide at the last dose level

Placebo comparator: Placebo - Double-Blind:

Participants receive placebo during the 30-week double-blind period.

Open-Label:

Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.


Treatment: Drugs: Tirzepatide Dose 1
Administered SC

Treatment: Drugs: Tirzepatide Dose 2
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
Change From Baseline in Hemoglobin A1c (HbA1c)
Timepoint [1] 0 0
Baseline, Week 30
Secondary outcome [1] 0 0
Change from Baseline in HbA1c (Individual Doses)
Timepoint [1] 0 0
Baseline, Week 30
Secondary outcome [2] 0 0
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched)
Timepoint [2] 0 0
Baseline, Week 30
Secondary outcome [3] 0 0
Change From Baseline in Fasting Serum Glucose (FSG)
Timepoint [3] 0 0
Baseline, Week 30
Secondary outcome [4] 0 0
Percentage of Participants Who Achieve =6.5% of HbA1c
Timepoint [4] 0 0
Week 30
Secondary outcome [5] 0 0
Percentage of Participants Who Achieve <7.0% of HbA1c
Timepoint [5] 0 0
Week 30
Secondary outcome [6] 0 0
Percentage of Participants Who Achieve <5.7% of HbA1c
Timepoint [6] 0 0
Week 30
Secondary outcome [7] 0 0
Change From Baseline for Serum Lipid Levels
Timepoint [7] 0 0
Baseline, Week 30
Secondary outcome [8] 0 0
Change From Baseline in Height Standard Deviation Score (SDS)
Timepoint [8] 0 0
Baseline, Week 30
Secondary outcome [9] 0 0
Change From Baseline in Weight SDS
Timepoint [9] 0 0
Baseline, Week 30
Secondary outcome [10] 0 0
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide
Timepoint [10] 0 0
Baseline to Week 30
Secondary outcome [11] 0 0
Change From Baseline in PedsQL Generic Core Scale
Timepoint [11] 0 0
Baseline, Week 52
Secondary outcome [12] 0 0
Change From Baseline PedsQL (3.2) Diabetic Module
Timepoint [12] 0 0
Baseline, Week 52

Eligibility
Key inclusion criteria
* Male or female, aged 10 to below 18 years at screening visit
* Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
* Have HbA1c >6.5% to =11% at screening
* Have body weight =50 kilogram (kg) 110 pounds and BMI of >85th percentile of the general age and gender-matched population for that country or region.
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
* After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
* Have had =1 episode of severe hypoglycemia and/or =1 episode of hypoglycemic unawareness within the last 6 months.
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
* Had chronic or acute pancreatitis any time prior to study entry
* Female participants who are pregnant or breast feeding or intending to become pregnant.
* Using prescription or over the counter medications for weight loss within 90 days of the screening visit.

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
13/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Centre for Children's Health Research - Brisbane
Recruitment hospital [3] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
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
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Brazil
State/province [10] 0 0
Espírito Santo
Country [11] 0 0
Brazil
State/province [11] 0 0
Paraná
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio Grande Do Sul
Country [13] 0 0
Brazil
State/province [13] 0 0
São Paulo
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio De Janeiro
Country [15] 0 0
France
State/province [15] 0 0
Maine-et-Loire
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
India
State/province [17] 0 0
Delhi
Country [18] 0 0
India
State/province [18] 0 0
Gujarat
Country [19] 0 0
India
State/province [19] 0 0
Karnataka
Country [20] 0 0
India
State/province [20] 0 0
Maharashtra
Country [21] 0 0
India
State/province [21] 0 0
Tamil Nadu
Country [22] 0 0
India
State/province [22] 0 0
Chandigarh
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
Italy
State/province [27] 0 0
Campania
Country [28] 0 0
Italy
State/province [28] 0 0
Veneto
Country [29] 0 0
Italy
State/province [29] 0 0
Ancona
Country [30] 0 0
Mexico
State/province [30] 0 0
Nuevo León
Country [31] 0 0
Mexico
State/province [31] 0 0
Tamaulipas
Country [32] 0 0
Mexico
State/province [32] 0 0
Chihuahua
Country [33] 0 0
Mexico
State/province [33] 0 0
Puebla
Country [34] 0 0
Mexico
State/province [34] 0 0
Veracruz
Country [35] 0 0
United Kingdom
State/province [35] 0 0
England
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Kingston Upon Hull
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Leicestershire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
1-877-CTLilly (1877-285-4559) 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05260021