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)

Official Summary

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Eligibility Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 2,539 participants

Study Arms

• Placebo (PLACEBO_COMPARATOR)
  * Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received once weekly (QW) subcutaneous (SC) doses of a matching placebo, administered over a period of 72 weeks. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the placebo dose SC QW until week 176. * Safety Follow-up Period: Part
• 5 mg Tirzepatide (EXPERIMENTAL)
  * Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks until reaching a dose of 5 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the
• 10 mg Tirzepatide (EXPERIMENTAL)
  * Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 10 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 10 mg tirze
• 15 mg Tirzepatide (EXPERIMENTAL)
  * Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received QW SC doses of tirzepatide, starting at 2.5 mg and increasing by 2.5 mg every 4 weeks until reaching a dose of 15 mg, which was then maintained up to week 72. * Additional Treatment Period (Week 72-Week 176): At week 72, only participants who had prediabetes at the time of randomization and had completed the primary treatment period continued receiving the 15 mg tirze

Interventions

• DRUG: Tirzepatide — Administered SC
• DRUG: Placebo — Administered SC

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)

Secondary Outcomes

• Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) - Primary Treatment Period (Baseline, Week 20)
• Percentage of Participants Who Achieve ≥10% Body Weight Reduction (Primary Treatment Period) (Week 72)
• Percentage of Participants Who Achieve ≥15% Body Weight Reduction (Primary Treatment Period) (Week 72)
• Percentage of Participants Who Achieve ≥20% Body Weight Reduction (Primary Treatment Period) (Week 72)
• Change From Baseline in Waist Circumference (Primary Treatment Period) (Baseline, Week 72)

Eligibility Criteria

Inclusion Criteria:

* Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
* History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Diabetes mellitus
* Change in body weight greater than 5 kg within 3 months prior to starting study
* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
* History of pancreatitis
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Any lifetime history of a suicide attempt

Trial Locations

• Cahaba Research, Pelham, Alabama, United States
• Perseverance Research Center, Scottsdale, Arizona, United States
• John Muir Physician Network Clinical Research Center, Concord, California, United States
• Valley Research, Fresno, California, United States
• National Research Institute - Wilshire, Los Angeles, California, United States
• Catalina Research Institute, LLC, Montclair, California, United States
• Encompass Clinical Research, Spring Valley, California, United States
• University Clinical Investigators, Inc., Tustin, California, United States
• Yale University School of Medicine, New Haven, Connecticut, United States
• Chase Medical Research, LLC, Waterbury, Connecticut, United States
• ...and 10 more locations

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) — STUDY_DIRECTOR
  Eli Lilly and Company

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