DelfaGLP-1 Atlas

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SURMOUNT-1

RecruitingPhase 3

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)

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)

Lead sponsor

Hudson Biotech

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

2,539

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07481747
Org study IDI8F-MC-GPHK(b)

Timeline

Milestones

Study start2026-02-02actual
Study first posted2026-03-19actual
Last update posted2026-03-19actual
Primary completion2027-02-14estimated
Study completion2028-03-17estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•BMI ≥30 kg/m², OR BMI ≥27 kg/m² with ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease)
•History of at least one unsuccessful dietary effort to lose weight (self-reported)
•Investigator judges participant capable and willing to self-inject (or have assistance), follow lifestyle advice, maintain a diary, and complete questionnaires
•Age ≥18 years
•Meets protocol contraception/pregnancy criteria (as applicable) and provides written informed consent

Exclusion criteria

•Type 1 or type 2 diabetes, history of ketoacidosis/hyperosmolar state, or screening labs diagnostic of diabetes
•Recent significant weight change (>5 kg within 3 months prior to screening)
•Prior/planned bariatric surgery; recent/ongoing endoscopic or device-based obesity therapies
•Severe renal impairment (eGFR <30 mL/min/1.73 m²)
•Clinically significant gastric emptying abnormality or chronic use of drugs that directly affect GI motility
•History of chronic or acute pancreatitis
•Clinically significant thyroid abnormalities at screening (e.g., TSH outside protocol range) or anticipated need to initiate thyroid replacement during study
•Obesity due to other endocrinologic disorders (e.g., Cushing syndrome) or monogenic/syndromic obesity (e.g., MC4R deficiency, Prader-Willi syndrome)
•Significant unstable major depressive disorder/severe psychiatric disorder, lifetime suicide attempt, or concerning suicidality screening (PHQ-9/C-SSRS criteria)
•Uncontrolled hypertension; recent major cardiovascular events; NYHA class IV heart failure
•Active or significant liver disease or certain elevated liver tests at screening (per protocol thresholds)
•Elevated calcitonin above protocol thresholds; personal/family history of medullary thyroid carcinoma or MEN2
•Active/untreated malignancy or remission <5 years (with specified exceptions)
•Any other condition contraindicating GLP-1 receptor agonist therapy

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
3
Cardiometabolic biomarkers
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Mean percent change in body weight from randomization

Time frame:72 Weeks

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of participants achieving ≥5% body weight reduction from randomization

Time frame:72 Weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Mean change in body weight

Time frame:72 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Changes in cardiometabolic measures in triglycerides

Time frame:72 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.