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Tirzepatide for Healthy Subjects

Phase 1
Recruiting
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 30 days postdose
Awards & highlights

Study Summary

This trial studies if a drug passes into breast milk & how long it takes the body to get rid of it. 8 wks incl. screening for each participant.

Who is the study for?
This study is for healthy breastfeeding women with a BMI between 18.5 and 40.0 kg/m², who are at least 6 weeks postpartum. Participants must have well-established lactation but agree to stop breastfeeding from the start of the trial until after a follow-up visit or for 29 days if they leave the study early. Women with diabetes or drug abuse history cannot join.Check my eligibility
What is being tested?
The trial tests Tirzepatide's presence in breast milk when given as a single injection under the skin to healthy lactating females. It aims to understand how long it stays in their system over an approximately eight-week period, including screening time.See study design
What are the potential side effects?
Potential side effects are not detailed here, but generally, any medication can cause reactions ranging from mild (like local discomfort where injected) to more significant systemic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 30 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 30 days postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve in Breast Milk From Zero to Infinity (AUC [0-∞]) of Tirzepatide

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%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: TirzepatideExperimental Treatment1 Intervention
A single dose of tirzepatide administered subcutaneously (SC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7590

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,546 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,740 Total Patients Enrolled

Media Library

Tirzepatide (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05978713 — Phase 1
Healthy Subjects Research Study Groups: Tirzepatide
Healthy Subjects Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT05978713 — Phase 1
Tirzepatide (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05978713 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration (FDA) given authorization for Tirzepatide use?

"Because there is limited evidence to suggest both efficacy and safety, Tirzepatide was given a score of 1 on our team's scale from 1 to 3."

Answered by AI

Is it feasible to enroll in this clinical experiment at present?

"The data provided by clinicaltrials.gov suggests that this particular research project is not presently recruiting any patients - the last update being on July 31st, 2023. However, there are 794 other medical studies actively seeking participants at this moment in time."

Answered by AI

Who else is applying?

What site did they apply to?
Las Vegas Clinical Research Unit - PPD
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Tirzepatide (LY3298176) in Healthy Lactating Females
2023. "A Study of Tirzepatide (LY3298176) in Healthy Lactating Females". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05978713.
All > Paid Studies Las Vegas
~3 spots leftby Jul 2024
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