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Glucagon-like peptide-1 (GLP-1) receptor agonist
A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide
Phase 1
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 18
Summary
This trial tests tirzepatide in people with obesity to see how it affects calorie burning and food intake. The study lasts several months and involves multiple visits to the study center. Tirzepatide is a new treatment effective in managing obesity and type 2 diabetes.
Eligible Conditions
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)
Secondary study objectives
Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ)
Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE)
Change From Baseline to Week 18 in Body Fat Mass
+12 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
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
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 15 Milligram (mg) TirzepatideExperimental Treatment1 Intervention
Participants received 15 mg of tirzepatide QW by SC injection.
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo once weekly (QW) by Subcutaneous (SC) injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7520
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,329 Total Patients Enrolled
69 Trials studying Obesity
47,032 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,786 Total Patients Enrolled
52 Trials studying Obesity
25,837 Patients Enrolled for Obesity