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Looking for participantsPhase3

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Sponsor: Eli Lilly and Company

NCT ID: NCT06439277

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tirzepatide (drug), Placebo (drug)
How long the study runs
Study runs about 78 months (dates as stated)
About the drug or intervention
Tirzepatide — drug: Administered SC · Placebo — drug: Administered SC
Patient visit burden
"The study will last approximately 76 weeks and may include up to 23 visits." (as stated by sponsor)
Type of study
Testing a treatment
Ages
12 Years to 17 Years
Who
All
Number of participants
300
Started
2024-06-03
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for obesity
  • • Phase3 - 300 participants
  • • 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

Who can take part?

  • • Ages 12 Years to 17 Years
  • • Diagnosed with obesity

Where?

  • • Cambridge - Addenbrooke's Hospital
  • • Glagow - Royal Hospital for Children
  • • Leeds - Leeds General Infirmary
  • • Leicester - Leicester Royal Infirmary
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

More detail

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.

ObesityWeight Gain

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years - 17 Years
  • Who can join: All genders

What the study is looking for

  • ✓Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
  • ✓Are capable of giving signed agreement to take part by a legal representative or assent by a study participant (when...

Who cannot take part

  • ✗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.
See the full criteria
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). 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

Where Is This Study? (9 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0SL, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Royal Hospital for Children

Glagow G51 4TF, United Kingdom

ACTIVE_NOT_RECRUITING

Leeds General Infirmary

Leeds LS1 3EX, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Alder Hey Children's Hospital

Liverpool L14 5AB, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Kelly Davies

research@alderhey.nhs.uk0151 2525570

Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital

London WC1E 6DB, United Kingdom

COMPLETED

Royal Victoria Infirmary

Newcastle upon Tyne NE1 4PL, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Sheffield Children's Hospital

Sheffield S10 2TH, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09