LivingGLP1
Study S001077

Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT04184622
Acronym
SURMOUNT-1
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
2539
Start
2019-12-04
Primary completion
2022-04-01
Lead sponsor
Eli Lilly and Company
Conditions
Overweight; Obesity
Interventions
DRUG:Tirzepatide; DRUG:Placebo
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:I8F-MC-GPHK

Registered primary outcomes

  • Percent Change From Baseline in Body Weight (Primary Treatment Period) [Baseline, Week 72]
  • Percentage of Participants Who Achieve ≥5% Body Weight Reduction (Primary Treatment Period) [Week 72]

Linked records (26)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0003816Comprehensive Long-Term Changes in Cardiovascular Risk Biomarkers With Tirzepatide: A SURMOUNT-1 Post Hoc Analysis.
Sattar N, Journal of the American College of Cardiology
2026Randomized trialPMID 42233927DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:42233927
R0007749Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT.
Wadden TA, Obesity (Silver Spring, Md.)
2026Other trialPMID 41537305DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:41537305
R0012329Evaluation of clinical relevance of weight nadirs and weight regain during 3 years of treatment with tirzepatide in participants with obesity or overweight and prediabetes.
Aronne LJ, Obesity pillars
2026Randomized trialPMID 42831032DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:42831032
R0013565Tirzepatide Efficacy and Tolerability According to Early Weight Response: A Post Hoc Analysis of the SURMOUNT-1 and SURMOUNT-2 Trials.
Kokkinos A, Diabetes, obesity & metabolism
2026Randomized trialPMID 42348366DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:42348366
R0014369Efficacy and Safety of Tirzepatide in Japanese Participants With Obesity: A Subpopulation Analysis of the SURMOUNT-1 Trial.
Ishigaki Y, Obesity (Silver Spring, Md.)
2026Other trialPMID 41612966DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:41612966
R0014849Nutritional status with tirzepatide in obesity: A post hoc analysis of the SURMOUNT-1-4 randomized clinical trials.
Almandoz JP, Obesity pillars
2026Randomized trialPMID 41640675DOIcites ClinicalTrials.gov:NCT04184622
R0015470People With Lowest Physical Functioning Scores Showed Greatest Improvement After Tirzepatide Treatment.
Li X, Obesity (Silver Spring, Md.)
2026Other trialPMID 41187013DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:41187013
R0016032Weight Changes With Tirzepatide and Concomitant Weight-Inducing Medications: Post Hoc Analysis of Randomized Clinical Trials.
Galindo RJ, JAMA network open
2026Systematic reviewPMID 41885866DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:41885866
R0016998Achieving BMI <25 kg/m2 was associated with reduced predicted risk of atherosclerotic cardiovascular disease in people with obesity or overweight on tirzepatide or placebo: a post hoc analysis of SURMOUNT-1, -3, and -CN.
Guo L, EClinicalMedicine
2026Randomized trialPMID 41536939DOIcites ClinicalTrials.gov:NCT04184622
R0038516Prevalence of eligibility for dual GIP/GLP-1 receptor agonists among non-diabetic and overweight adults - a Portuguese community-based study
H Santos Moreira, European Journal of Heart Failure
2026Other trialDOIcites ClinicalTrials.gov:NCT04184622
R0006704Association between weight reduction achieved with tirzepatide and quality of life in adults with obesity: Results from the SURMOUNT-1 study.
Gudzune KA, Diabetes, obesity & metabolism
2025Other trialPMID 39497468DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:39497468
R0008984Visual demonstration of weight loss and health risk improvement with a dual GIP and GLP-1 receptor agonist.
Ramirez S, International journal of obesity (2005)
2025Other trialPMID 40659850DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:40659850
R0016263Weight reduction over time in tirzepatide-treated participants by early weight loss response: Post hoc analysis in SURMOUNT-1.
Ard J, Diabetes, obesity & metabolism
2025Other trialPMID 40677091DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:40677091
R0016446Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials.
Gourgari E, Obesity (Silver Spring, Md.)
2025Randomized trialPMID 40717199DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:40717199
R0016891Kidney Parameters with Tirzepatide in Obesity with or without Type 2 Diabetes.
Heerspink HJL, Journal of the American Society of Nephrology : JASN
2025Randomized trialPMID 40512543DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:40512543
R0017458Time to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials.
Horn DB, Clinical obesity
2025Randomized trialPMID 39800653DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:39800653
R0017565Improvements in Cardiometabolic Risk Factors by Weight Reduction: A Post Hoc Analysis of Adults With Obesity Randomly Assigned to Tirzepatide.
Linetzky B, Annals of internal medicine
2025Randomized trialPMID 40550133DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:40550133
R0017665Tirzepatide for Obesity Treatment and Diabetes Prevention.
Jastreboff AM, The New England journal of medicine
2025Randomized trialPMID 39536238DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:39536238
R00498521729-P: Achieving BMI <25 kg/m2 Was Associated with Reduced Predicted Risk of Atherosclerotic Cardiovascular Disease in People with Obesity or Overweight—A Post Hoc Analysis of SURMOUNT-1, -3, and -CN
Lixin Guo, Diabetes
2025Randomized trialDOIcites ClinicalTrials.gov:NCT04184622
R0018082Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial.
Krumholz HM, Heart (British Cardiac Society)
2024Randomized trialPMID 39084707DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:39084707
R0019674Tirzepatide Reduces 24-Hour Ambulatory Blood Pressure in Adults With Body Mass Index ≥27 kg/m2: SURMOUNT-1 Ambulatory Blood Pressure Monitoring Substudy.
de Lemos JA, Hypertension (Dallas, Tex. : 1979)
2024CommentaryPMID 38314555DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:38314555
R0008073Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program.
le Roux CW, Obesity (Silver Spring, Md.)
2023ProtocolPMID 36478180DOIcites ClinicalTrials.gov:NCT04184622
R0019477Tirzepatide reduces the predicted risk of developing type 2 diabetes in people with obesity or overweight: Post hoc analysis of the SURMOUNT-1 trial.
Hankosky ER, Diabetes, obesity & metabolism
2023Randomized trialPMID 37700443DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:37700443
R0047034Tirzepatide maintained significant weight loss when treatment was continued in a follow‐up study
ISKANDAR RAUF IDRIS, Diabetes Obesity and Metabolism Now
2023Randomized trialDOIcites ClinicalTrials.gov:NCT04184622
R0010987Tirzepatide Once Weekly for the Treatment of Obesity.
Jastreboff AM, The New England journal of medicine
2022Randomized trialPMID 35658024DOIcites ClinicalTrials.gov:NCT04184622; registry reference DERIVED:35658024
R0023137Tirzepatide-Friend or Foe in Diabetic Cancer Patients?
Samuel SM, Biomolecules
2022Other trialPMID 36358930DOIcites ClinicalTrials.gov:NCT04184622