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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-06-03

Primary completion: 2027-05-01

Study completion finish: 2027-06-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06439277

Intervention or treatment

DRUG: Tirzepatide

DRUG: Placebo

Conditions

• Obesity
• Weight Gain

Condition: Obesity, Weight Gain
DRUG: Tirzepatide and other drugs
Westmead, New South Wales, Australia and more
Sponsor: Eli Lilly and Company

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Children's Hospital at Westmead

Research sites nearby

Select from list below to view details:

The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Perth Children's Hospital
Perth, Western Australia, Australia
Hunter Medical Research Institute
Newcastle, New South Wales, Australia
University of Sydney - Charles Perkins Centre
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Tirzepatide Participants will receive tirzepatide subcutaneously (SC).	DRUG: Tirzepatide Administered SC
PLACEBO_COMPARATOR: Placebo Participants will receive placebo SC.	DRUG: Placebo Administered SC

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Percent Change from Baseline in Body Mass Index (BMI)	Not Specified	Baseline, Week 72
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	Not Specified	Baseline, Week 72

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Percentage of Participants Who Achieve BMI Reduction of ≥ 5%	Not Specified	Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 10%	Not Specified	Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 15%	Not Specified	Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 20%	Not Specified	Week 72
Change from Baseline in Hemoglobin A1c (HbA1c)	Not Specified	Baseline, Week 72
Percent Change from Baseline in Triglycerides	Not Specified	Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)	Not Specified	Baseline, Week 72
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)	Not Specified	Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)	Not Specified	Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure (DBP)	Not Specified	Baseline, Week 72
Percent Change from Baseline in Body Weight	Not Specified	Baseline, Week 72
Change from Baseline in Waist Circumference	Not Specified	Baseline, Week 72

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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