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Placebo

Tirzepatide for Weight Loss Maintenance in Obesity

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
Be older than 18 years old
Must not have
Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma
Have a history of chronic or acute pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 112
Awards & highlights
Pivotal Trial

Summary

This trial is testing tirzepatide, a medication that helps people lose weight, to see if it can also help them keep the weight off. The study involves people who have already lost weight and need help maintaining it. Tirzepatide works by making people feel full and reducing their appetite. Tirzepatide has been effective in helping people lose weight and manage blood sugar levels.

Who is the study for?
This trial is for adults with obesity or overweight who have related health issues like high blood pressure, sleep apnea, or heart disease. They should have tried to lose weight before without success. People with severe depression, diabetes, recent major heart problems, significant weight changes in the last 3 months, pancreatitis, or a family history of certain thyroid cancers cannot join.
What is being tested?
The study tests Tirzepatide's ability to help maintain weight loss compared to a placebo (a treatment with no active drug). Participants will be randomly assigned to receive either Tirzepatide or the placebo and monitored for effectiveness and safety.
What are the potential side effects?
Possible side effects of Tirzepatide may include digestive issues such as nausea and diarrhea, potential low blood sugar levels especially if taking other diabetes medications concurrently, increased heart rate and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is over 27 and I have a weight-related health issue like high blood pressure or heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes and a history of severe diabetic complications.
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I have a history of pancreatitis.
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I haven't had severe depression or serious mental health issues in the last 2 years.
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I or my family have a history of MTC or MEN-2.
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I haven't had a heart attack, stroke, severe chest pain, or been hospitalized for heart failure in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 112
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 112 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
Secondary study objectives
Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization
Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Tirzepatide
15 mg Tirzepatide

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tirzepatide Maximum Tolerated DoseExperimental Treatment1 Intervention
Participants will receive tirzepatide SC.
Group II: Tirzepatide 5 milligram (mg)Experimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7520

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Tirzepatide, a dual GIP and GLP-1 receptor agonist, and other GLP-1 receptor agonists work by mimicking incretin hormones that enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. These actions collectively reduce appetite and caloric intake, leading to significant weight loss. For obesity patients, these treatments are important because they address both weight reduction and metabolic improvements, which can help manage obesity-related comorbidities such as type 2 diabetes and cardiovascular diseases.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,654 Previous Clinical Trials
3,224,304 Total Patients Enrolled
64 Trials studying Obesity
53,325 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,378 Previous Clinical Trials
423,188 Total Patients Enrolled
46 Trials studying Obesity
32,867 Patients Enrolled for Obesity
~237 spots leftby May 2026