SURPASS-PEDS: 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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05260021

Collaborator

(none)

Enrollment

Locations

Arms

68.6

Anticipated Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.

The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 T2D T2DM (Type 2 Diabetes Mellitus) Glucose Metabolism Disorders Endocrine System Diseases Metabolic Disease	Drug: Tirzepatide Dose 1 Drug: Tirzepatide Dose 2 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Apr 13, 2022

Anticipated Primary Completion Date :

Nov 30, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Tirzepatide Dose 1 Administered SC
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	Drug: Tirzepatide Dose 2 Administered SC
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.	Drug: Tirzepatide Dose 1 Administered SC Drug: Placebo Administered SC

Arm

Intervention/Treatment

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

Drug: Tirzepatide Dose 1

Administered SC

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

Drug: Tirzepatide Dose 2

Administered SC

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.

Drug: Tirzepatide Dose 1

Administered SC

Drug: Placebo

Administered SC

Outcome Measures

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 30]

Secondary Outcome Measures

Change from Baseline in HbA1c (Individual Doses) [Baseline, Week 30]
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched) [Baseline, Week 30]
Change From Baseline in Fasting Serum Glucose (FSG) [Baseline, Week 30]
Percentage of Participants Who Achieve ≤6.5% of HbA1c [Week 30]
Percentage of Participants Who Achieve <7.0% of HbA1c [Week 30]
Percentage of Participants Who Achieve <5.7% of HbA1c [Week 30]
Change From Baseline for Serum Lipid Levels [Baseline, Week 30]
Change From Baseline in Height Standard Deviation Score (SDS) [Baseline, Week 30]
Change From Baseline in Weight SDS [Baseline, Week 30]
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide [Baseline to Week 30]
Change From Baseline in PedsQL Generic Core Scale [Baseline, Week 52]
The PedsQL Generic Core Scale has 23 items that measure the core dimensions of health: physical, emotional, and social and school functioning. Scores range from 0 to 100. Higher scores indicate better health related quality of life.
Change From Baseline PedsQL (3.2) Diabetic Module [Baseline, Week 52]
The PedsQL 3.2 Diabetes Module has 33 items for ages 13 to 45 years, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms, treatment barriers, treatment adherence, worry and communication. Scores range from 0 to 100. Higher scores indicate less problems.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
3	Center Of Excellence in Diabetes and Endocrinology	Sacramento	California	United States	95821
4	Rady Children's Hospital	San Diego	California	United States	92123
5	Touro University California	Vallejo	California	United States	94592
6	Children's Hospital Colorado	Aurora	Colorado	United States	80045
7	Yale University School of Medicine	New Haven	Connecticut	United States	06519
8	Nemours Childrens Clinic - Delaware Valley of The Nemours Foundation	Wilmington	Delaware	United States	19803
9	Qualmedica Research, LLC	Evansville	Indiana	United States	47715
10	Indiana University Health University Hospital	Indianapolis	Indiana	United States	46202
11	AA Medical Research Center	Flint	Michigan	United States	48504
12	Washington University	Saint Louis	Missouri	United States	63110
13	SUNY Downstate Health Sciences University	Brooklyn	New York	United States	11203
14	SUNY Upstate Medical University	Syracuse	New York	United States	13210
15	Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania	United States	19104
16	Consano Clinical Research, LLC	Shavano Park	Texas	United States	78231
17	The Children's Hospital at Westmead	Westmead	New South Wales	Australia	2145
18	Centre for Children's Health Research	Brisbane	Queensland	Australia	4101
19	Perth Children's Hospital	Perth	Western Australia	Australia	6009
20	CEDOES	Vitória	Espírito Santo	Brazil	29055450
21	Centro de Diabetes Curitiba	Curitiba	Paraná	Brazil	80810-040
22	Instituto Méderi de Pesquisa e Saúde	Passo Fundo	Rio Grande Do Sul	Brazil	99010-120
23	Instituto da Crianca com Diabetes	Porto Alegre	Rio Grande Do Sul	Brazil	91350-250
24	Centro de Pesquisa Sao Lucas	Campinas	São Paulo	Brazil	13034-685
25	Instituto de Pesquisa clinica de Campinas	Campinas	São Paulo	Brazil	13060-080
26	Instituto de Pesquisa Clinica	Sao Paulo	São Paulo	Brazil	01223-001
27	Instituto da Crianca do Hospital das Clinicas da FMUSP	Sao Paulo	São Paulo	Brazil	05403-000
28	Ruschel Medicina e Pesquisa Clínica	Rio De Janeiro		Brazil	22270-060
29	CPQuali Pesquisa Clínica	São Paulo		Brazil	01228-000
30	CEPIC - Centro Paulista de Investigação Clínica	São Paulo		Brazil	04266-010
31	Centre Hospitalier Universitaire d'Angers	Angers	Maine-et-Loire	France	49933
32	Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (CHU)	Paris		France	75019
33	All India Institute of Medical Sciences	New Delhi	Delhi	India	110029
34	Gujarat Endocrine Center	Ahmedabad	Gujarat	India	380006
35	M S Ramaiah Medical College and Hospitals	Bangalore	Karnataka	India	560054
36	Bhakti Vedanta Hospital and Research Institute	Thane	Maharashtra	India	401107
37	Kovai Diabetes Speciality Center and Hospital	Coimbatore	Tamil Nadu	India	641009
38	Postgraduate Institute of Medical Education & Research	Chandigarh		India	160012
39	Soroka Medical Center	Be'er Sheva	HaDarom	Israel	8410101
40	Yitzhak Shamir Medical Center	Beer Yaacov	HaMerkaz	Israel	70300
41	Sheba Medical Center	Ramat Gan	HaMerkaz	Israel	5262100
42	Rambam Health Care Campus	Haifa	HaTsafon	Israel	3109601
43	Shaare Zedek Medical Center	Jerusalem	Yerushalayim	Israel	9013102
44	Universita degli Studi della Campania Luigi Vanvitelli	Napoli	Campania	Italy	80138
45	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento	Verona	Veneto	Italy	37126
46	Ospedale Pediatrico Salesi	Ancona		Italy	60123
47	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Nuevo León	Mexico	66465
48	Clínica Cemain	Tampico	Tamaulipas	Mexico	89170
49	Investigacion En Salud Y Metabolismo Sc	Chihuahua		Mexico	31217
50	Hospital Angeles Puebla	Puebla		Mexico	72190
51	Arké SMO S.A de C.V	Veracruz		Mexico	91910
52	Clínica Juaneda	Palma de Mallorca	Balears [Baleares]	Spain	07014
53	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona [Barcelona]	Spain	08950
54	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
55	Hull Royal Infirmary - MAIN	Hull	Kingston U	United Kingdom	HU3 2JZ
56	Leicester General Hospital	Leicester	Leicestershire	United Kingdom	LE5 4PW