ObesityPhase 3NCT06075667
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
A Phase 3 study testing Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 33 sites in 6 countries.
Trial summary
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 16 Oct 2023to Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
- Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
- dyslipidemia
- pre-hypertension
- hypertension
- nonalcoholic fatty liver disease
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- obstructive sleep apnea
- prediabetes
- documented preexisting condition of Type 2 Diabetes
- Participants with Type 2 Diabetes Mellitus (T2DM)
- Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0%
Who cannot join
- Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
- Have Type 1 Diabetes
- Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
- Are prepubertal (Tanner stage 1).
- Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
- Have a history of chronic or acute pancreatitis.
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- Have undergone or plan to undergo 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.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States10 sites
Barry J. Reiner, MD, LLC
Baltimore, Maryland, 21229
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Aventiv Research Inc
Columbus, Ohio, 43213
PriMED Clinical Research
Dayton, Ohio, 45429
CenExel iResearch, LLC
Decatur, Georgia, 30030
Solaris Clinical Research
Meridian, Idaho, 83646
M Health Fairview - Delaware Clinical Research Unit (DCRU)
Minneapolis, Minnesota, 55414
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 372212
Washington University School of Medicine
St Louis, Missouri, 63110
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
Israel7 sites
Emek Medical Center
Afula, Northern District, 1834111
Yitzhak Shamir Medical Center
Beer Yaacov, Central District, 70300
Soroka Medical Center
Beersheba, Southern District, 8410101
Rambam Health Care Campus
Haifa, Northern District, 3109601
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102
Schneider Children's Medical Center
Petah Tikva, Central District, 4920235
Sheba Medical Center
Ramat Gan, Central District, 5262100
Czechia5 sites
Nemocnice Jihlava
Jihlava, 58633
ReFit Clinic
Olomouc, Olomouc Region, 779 00
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, Ostrava Město, 703 84
Fakultni nemocnice v Motole
Prague, Praha 5, 150 06
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Canada4 sites
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6
Alberta Diabetes Institute
Edmonton, Alberta, T6G 2E1
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, Ontario, L8L 5G8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Italy4 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138
Azienda Ospedaliera Universitaria Di Messina G. Martino
Messina, 98125
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Veneto, 37126
Poland3 sites
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Uniwersyteckie Centrum Pediatrii im. M. Konop -T
Lodz, Łódź Voivodeship, 91-738
Instytut Diabetologii
Warsaw, Masovian Voivodeship, 02-117
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, Silesian Voivodeship, 41-800
About this study
Official title: Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.
Participants who have completed the primary 72-week GPHP 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.
- Conditions
- Obesity, Overweight
- Being tested
- Tirzepatide, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide subcutaneously (SC). Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 72
Secondary outcomes (11)
Percentage of Participants with ≥5% BMI Reduction
Measured: Baseline, Week 72
Change from Baseline in Body Weight
Measured: Baseline, Week 72
Change from Baseline in Waist Circumference
Measured: Baseline, Week 72
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score
Measured: Baseline, Week 72
Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts
Measured: Baseline, Week 72
Change from Baseline in Systolic Blood Pressure
Measured: Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure
Measured: Baseline, Week 72
Percent Change from Baseline in Total Cholesterol
Measured: Baseline, Week 72
Change from Baseline in Fasting Glucose
Measured: Baseline, Week 72
Change from Baseline in Fasting Insulin
Measured: Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
AUC is presented as a single average measure of AUC across the study duration.
Measured: Baseline through Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start16 Oct 2023
- Primary completion2 Jun 2026
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075667
- Sponsor's protocol ID
- 17365
- Other IDs
- I8F-MC-GPHP, 2023-504413-80-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 4 Oct 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)
- ClinicalTrials.gov ID
- NCT06075667
- Acronym / sponsor ID
- 17365
- Conditions
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- Jul 2029 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.
Participants who have completed the primary 72-week GPHP 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideParticipants will receive tirzepatide subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
- Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
- Participants with Type 2 Diabetes Mellitus (T2DM)
- Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0%
Key exclusion criteria (11 listed)
- Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
- Have Type 1 Diabetes
- Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
- Are prepubertal (Tanner stage 1).
- Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC | Drug | Tirzepatide |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percent Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 72
11 secondary outcomes
Percentage of Participants with ≥5% BMI Reduction
Time frame: Baseline, Week 72
Change from Baseline in Body Weight
Time frame: Baseline, Week 72
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 72
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score
Time frame: Baseline, Week 72
Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts
Time frame: Baseline, Week 72
Change from Baseline in Systolic Blood Pressure
Time frame: Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure
Time frame: Baseline, Week 72
Percent Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 72
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 72
Change from Baseline in Fasting Insulin
Time frame: Baseline, Week 72
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Time frame: Baseline through Week 72
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related ComorbiditiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 33 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Israel, Czechia, Canada, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in Body Mass Index (BMI) (time frame: Baseline, Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.