Obesity / Tirzepatide / Weight Gain · Phase 3 Trial

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

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 registration for SURMOUNT-ADOLESCENTS-2, a tirzepatide trial in adolescents with obesity and weight-related comorbidities. No results have been posted in this registry record. The study is currently recruiting and outcomes will not be available until completion of the 72-week primary phase.

What was studied

Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Obesity, Weight Gain; age from 12 Years; to 17 Years. Intervention: Tirzepatide. Compared with: Placebo — Placebo Comparator. n = 300. 70 sites across 12 countries.

Key findings

Safety

The source does not report effect sizes, p-values, confidence intervals, or any efficacy or safety data.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 trial registration with no results posted; the study is actively recruiting and outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Percent Change from Baseline in Body Mass Index (BMI) (assessed at 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 P… (assessed at Baseline, Week 72)

DesignPhase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationObesity, Weight Gain; age from 12 Years; to 17 Years

Sample size300

InterventionTirzepatide

ComparatorPlacebo — Placebo Comparator

Setting70 sites across 12 countries

Reported figures

Quoted from the source exactly as published.

Estimated enrollment300

Study phasePhase 3

Primary outcome measure 1Percent Change from Baseline in Body Mass Index (BMI), measured at Baseline and Week 72

Primary outcome measure 2Composite 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, measured at Baseline and Week 72

Study durationApproximately 76 weeks for primary phase; up to 156 weeks additional for completers of prior GPIX study

Caveats

This is a registry record with no results posted; outcomes are not yet available.
Recruitment is ongoing; final sample size may differ from the estimated 300 participants.
Detailed study methods (randomization ratio, blinding, inclusion/exclusion criteria, dosing schedule) are not provided in this registry extract.
The source does not report effect sizes, p-values, confidence intervals, or any efficacy or safety data.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 randomized controlled trial with placebo comparator.

Directness

strong

Adolescents with obesity and weight-related comorbidities; hard endpoints including BMI and comorbidity improvement.

Consistency

insufficient

No results yet reported; consistency cannot be assessed.

Risk of bias

insufficient

Study design supports blinding and randomization, but full methods and conduct details not provided.

Sample adequacy

moderate

Estimated 300 participants enrolled; adequate for Phase 3 but enrollment ongoing, final N unknown.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06439277). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Obesity, Weight Gain. Interventions: DRUG: Tirzepatide; DRUG: Placebo. Primary outcome measures: Percent Change from Baseline in Body Mass Index (BMI) , 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 , Baseline, Week 72. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Eli Lilly and CompanyObesityTirzepatideNCT06439277Weight Gain