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

Clinical trial · Hudson Biotech

- Archive id: nct:NCT07481747
- Published: 2026-03-19
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07481747
- Source URL: https://clinicaltrials.gov/study/NCT07481747
- Provenance: clinicaltrials

## Abstract

This Phase 3 study evaluates the efficacy and safety of once-weekly subcutaneous tirzepatide (a dual GIP and GLP-1 receptor agonist) at 5 mg, 10 mg, or 15 mg versus placebo, each used with a reduced-calorie diet and increased physical activity, in adults without type 2 diabetes who have obesity or are overweight with weight-related comorbidities. The primary efficacy assessment is at Week 72. Participants with prediabetes at randomization may continue in an additional long-term treatment period to assess progression to type 2 diabetes and longer-term weight outcomes.

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- acronym: SURMOUNT-1
- status: RECRUITING
- phase: PHASE3
- study type: INTERVENTIONAL
- enrollment: 2539
- sponsor: Hudson Biotech
- conditions: Obesity; Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
- interventions: DRUG: Tirzepatide; DRUG: Placebo; BEHAVIORAL: Reduced-calorie diet
- start date: 2026-02-02
- start date type: ACTUAL
- primary completion date: 2027-02-14
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [GLP-1 & Incretin Therapies](https://space-kitty.com/topics/glp1-metabolic)

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