Phase 3 N=751 Randomized Treatment

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Obesity · Overweight

Bottom Line

View on ClinicalTrials.gov: NCT05822830 ↗

Enrolled (actual)

751

Serious AEs

4.1%

Results posted

Nov 2025

Primary outcome: Primary: Percent Change From Baseline in Body Weight — -20.2; -13.7 Percent change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tirzepatide (Drug); Semaglutide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Body Weight	-20.2; -13.7	—
SECONDARY Percentage of Participants Who Achieve ≥10% Body Weight Reduction	87.7; 66.7	—
SECONDARY Percentage of Participants Who Achieve ≥15% Body Weight Reduction	71.7; 45.0	—
SECONDARY Percentage of Participants Who Achieve ≥20% Body Weight Reduction	55.0; 31.1	—
SECONDARY Percentage of Participants Who Achieve ≥25% Body Weight Reduction	36.5; 18.6	—
SECONDARY Change From Baseline in Waist Circumference in Centimeter	-18.4; -13.0	—
SECONDARY Percentage of Participants Who Achieve ≥30% Body Weight Reduction	23.0; 8.2	—
SECONDARY Change From Baseline in Body Mass Index (BMI)	-8.5; -6.0	—
SECONDARY Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide	-21.8; -15.4	—

Summary

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

Eligibility Criteria

Inclusion Criteria

Have a body mass index (BMI) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
Have a history of at least 1 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05822830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.