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SURMOUNT Clinical Program

SURMOUNT is Eli Lilly’s phase 3 clinical-development program for tirzepatide in obesity, overweight, and related conditions. The program connects Eli Lilly, tirzepatide, Zepbound, GIP/GLP-1 receptor agonism, clinical evidence, and later regulatory actions.

The trial-status record reviewed here is current to July 23, 2026. ClinicalTrials.gov records can change as recruitment, follow-up, results reporting, and study plans progress; each trial link should be checked before treating a status as current.

Reference record

Section titled “Reference record”
Field SURMOUNT record
Entity type Clinical-development program
Sponsor Eli Lilly
Investigational intervention across the program Tirzepatide
Related US obesity product Zepbound
Mechanism GIP/GLP-1 receptor agonism
Main development phase Phase 3, with phase 3b and outcomes studies
Selected studied contexts Obesity or overweight with and without type 2 diabetes, maintenance, lifestyle-intervention sequencing, obstructive sleep apnea, active comparison, outcomes, and adolescents

The program name organizes related studies. It is not itself an active ingredient, product, indication, approval, or single trial result.

Program, trial, and product are different records

Section titled “Program, trial, and product are different records”
Record level SURMOUNT example Interpretation boundary
Clinical program SURMOUNT Umbrella relationship among multiple tirzepatide studies
Individual trial SURMOUNT-1, SURMOUNT-OSA, or SURMOUNT-5 One protocol with its own population, design, endpoints, dates, and analysis
Active ingredient Tirzepatide Molecule identity, not a trial or brand
Product Zepbound Branded regulatory and commercial record
Regulatory action FDA approval or label expansion Product-, indication-, population-, jurisdiction-, and date-specific decision

One trial may contribute to a regulatory evidence package, but the trial name and approved product label remain separate records.

Foundational adult studies

Section titled “Foundational adult studies”

The first four numbered SURMOUNT studies examined different populations or treatment sequences. All four registry records listed the studies as completed by the review date.

Study Registry Population and design distinction Status context
SURMOUNT-1 NCT04184622 Adults without type 2 diabetes who had obesity or overweight with weight-related comorbidities; randomized, double-blind, placebo-controlled phase 3 study with a longer extension for participants with prediabetes Completed; registry update posted July 24, 2025
SURMOUNT-2 NCT04657003 Adults with type 2 diabetes who had obesity or overweight; randomized, double-blind, placebo-controlled phase 3 study Completed; a distinct diabetes population from SURMOUNT-1
SURMOUNT-3 NCT04657016 Adults randomized after an intensive lifestyle-intervention lead-in Completed; the lead-in changes how results should be compared with other studies
SURMOUNT-4 NCT04660643 Randomized-withdrawal design after an open-label tirzepatide lead-in Completed; addresses continued treatment and maintenance rather than replicating SURMOUNT-1

The numbering does not imply that the studies share identical eligibility criteria, comparators, treatment periods, estimands, or analytical questions.

Obstructive-sleep-apnea studies

Section titled “Obstructive-sleep-apnea studies”

SURMOUNT-OSA used one master protocol covering two phase 3 studies in adults with moderate-to-severe obstructive sleep apnea and obesity. One study enrolled participants unable or unwilling to use positive airway pressure therapy; the other enrolled participants who planned to continue positive airway pressure therapy.

Record Detail
Registry NCT05412004
Program design Randomized, double-blind, placebo-controlled master protocol
Studies under the protocol GPI1 and GPI2
Enrollment 469 participants across the two studies
Registry status Completed; results posted
Regulatory relationship Supported the December 20, 2024 Zepbound obstructive-sleep-apnea indication

The FDA indication applies to moderate-to-severe obstructive sleep apnea in adults with obesity. It should not be generalized to every sleep disorder, OSA severity, age group, or person without obesity. The FDA approval notice and current Zepbound label provide the regulatory scope.

Active-comparator study

Section titled “Active-comparator study”

SURMOUNT-5 directly compared tirzepatide with semaglutide in adults with obesity or overweight and at least one weight-related comorbidity who did not have diabetes.

Record Detail
Registry NCT05822830
Phase Phase 3b
Design Randomized, open-label, active-controlled
Comparator Semaglutide
Registry status Completed; results posted November 26, 2025

The trial is more directly informative than an across-trial comparison, but its conclusions remain bounded by its eligibility criteria, open-label design, product regimens, endpoints, duration, estimand, and analysis. It does not make every tirzepatide and semaglutide product, indication, population, or presentation universally comparable.

Outcomes study

Section titled “Outcomes study”

SURMOUNT-MMO expands the program from weight-change trials into morbidity and mortality outcomes research.

Record Detail
Registry NCT05556512
Phase Phase 3
Population Adults with obesity
Research focus Reduction in morbidity and mortality outcomes
Registry status Active, not recruiting in the January 12, 2026 update
Results status No results posted on ClinicalTrials.gov as of that update

An ongoing outcomes study does not add an approved indication before a regulator reviews a submission and grants a product-specific authorization.

Adolescent development

Section titled “Adolescent development”

The adolescent studies remain separate from the current adult Zepbound label.

Study Registry Status as reviewed Interpretation boundary
SURMOUNT-ADOLESCENTS NCT06075667 Active, not recruiting; primary completion occurred June 2, 2026, with longer follow-up continuing Trial completion milestones do not establish pediatric approval
SURMOUNT-ADOLESCENTS-2 NCT06439277 The June 18, 2026 registry update listed the study as recruiting Separate protocol for adolescents with obesity and multiple weight-related comorbidities

The current Zepbound label states that safety and effectiveness have not been established in pediatric patients. Trial enrollment or a primary-completion date should not be described as approval, label expansion, or commercial availability.

Regulatory relationships

Section titled “Regulatory relationships”

SURMOUNT evidence connects to Zepbound through dated FDA actions rather than one program-wide approval.

Date Regulatory event Program relationship
November 8, 2023 FDA approved Zepbound for long-term weight reduction and maintenance in a defined adult population Connected pivotal adult tirzepatide evidence to the initial US obesity-product record
December 20, 2024 FDA approved Zepbound for moderate-to-severe obstructive sleep apnea in adults with obesity Connected SURMOUNT-OSA to a separate product indication
After 2024 Additional studies continued in outcomes, comparative, and adolescent settings These records remain evidence or development context unless incorporated into a regulator-approved label

The FDA original Zepbound approval notice, FDA OSA approval notice, and current product label define the approved US scope.

How to read SURMOUNT results

Section titled “How to read SURMOUNT results”

Result interpretation should preserve at least the following fields:

  • trial identifier and protocol
  • sponsor and intervention
  • studied population and exclusion criteria
  • diabetes status and other comorbidities
  • comparator and masking
  • lifestyle-intervention or treatment lead-in
  • randomized-withdrawal or parallel-group design
  • dose or titration strategy
  • primary and secondary endpoints
  • endpoint timing and study duration
  • estimand, missing-data handling, and analysis population
  • registry, publication, label, and regulatory-review dates

Mean percentage weight change, responder thresholds, sleep-apnea endpoints, maintenance outcomes, and morbidity or mortality outcomes answer different questions. They should not be merged into a single program-wide efficacy number.

Status interpretation

Section titled “Status interpretation”
Status or event What it supports What it does not establish
Recruiting The registry was seeking participants at the stated update Eventual completion, positive results, or approval
Active, not recruiting Study activity or follow-up continues without new recruitment Results availability or regulatory success
Primary completion Final collection for the primary outcome has occurred Full study completion, publication, or label change
Completed The registry marks the study complete That every analysis is published or incorporated into labeling
Results posted Structured registry results are available Universal applicability or product superiority
FDA approval A named product has an authorized use Approval of every study population, mechanism peer, or future asset

What not to infer

Section titled “What not to infer”
  • SURMOUNT is not another name for tirzepatide or Zepbound.
  • Results from one SURMOUNT trial do not automatically apply to another.
  • A trial in adults without diabetes is not equivalent to a trial in adults with type 2 diabetes.
  • Lifestyle lead-ins and randomized-withdrawal designs cannot be ignored in comparisons.
  • SURMOUNT-5 does not make all tirzepatide and semaglutide records interchangeable.
  • An adolescent trial does not establish pediatric approval.
  • An active outcomes trial does not establish an outcomes indication.
  • Trial completion, publication, or positive results do not establish launch, coverage, price, supply, or individual suitability.
  • This program record is not treatment, dosing, switching, or prescribing guidance.
Section titled “Related records”