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LY3437943 for High BMI

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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 up to 71 days postdose (part b)
Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a drug given SC and IV in participants with high BMI. It lasts up to 157 days.

Who is the study for?
This study is for healthy adults with a high BMI (27.0-45.0 kg/m²) who are willing to get injections under the skin or through a vein, and aren't pregnant or smoking heavily. People with allergies to LY3437943, diabetes, or conditions that affect drug absorption/metabolism can't join.Check my eligibility
What is being tested?
LY3437943 is being tested in two parts: Part A examines how it's absorbed and processed when injected under the skin in different body areas; Part B assesses safety/tolerability when given intravenously over approximately 99-157 days.See study design
What are the potential side effects?
Possible side effects of LY3437943 will be monitored during the trial but may include typical reactions at injection sites, general discomfort, or other unexpected issues related to medication tolerance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 up to 71 days postdose (part b)
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 up to 71 days postdose (part b) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: PK: Maximum Concentration (Cmax) of LY3437943
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
Secondary outcome measures
Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
Part B: PK: Maximum Concentration (Cmax) of LY3437943

Side effects data

From 2022 Phase 2 trial • 281 Patients • NCT04867785
20%
Decreased appetite
20%
Nausea
15%
Diarrhoea
11%
Constipation
11%
Vomiting
11%
Upper respiratory tract infection
11%
Urinary tract infection
7%
Fatigue
7%
Dyspepsia
4%
Anaemia
4%
Covid-19
4%
Lipase increased
4%
Dizziness
4%
Weight decreased
2%
Cellulitis
2%
Diabetic ketoacidosis
2%
Abdominal pain
2%
Eructation
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
12 mg LY3437943 (2 mg)
8 mg LY3437943 (2 mg)
Placebo
1.5 Milligram (mg) Dulaglutide
0.5 mg LY3437943
4 mg LY3437943 (2 mg)
4 mg LY3437943 (4 mg)
8 mg LY3437943 (4 mg)

Trial Design

2Treatment groups
Experimental Treatment
Group I: LY3437943 (Part B)Experimental Treatment1 Intervention
LY3437943 administered intravenously (IV)
Group II: LY3437943 (Part A)Experimental Treatment1 Intervention
LY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3437943
2022
Completed Phase 2
~950

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
2,622 Previous Clinical Trials
3,216,690 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,813 Total Patients Enrolled

Media Library

LY3437943 (Part A) Clinical Trial Eligibility Overview. Trial Name: NCT05959096 — Phase 1
Healthy Subjects Research Study Groups: LY3437943 (Part A), LY3437943 (Part B)
Healthy Subjects Clinical Trial 2023: LY3437943 (Part A) Highlights & Side Effects. Trial Name: NCT05959096 — Phase 1
LY3437943 (Part A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05959096 — Phase 1

Frequently Asked Questions

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

Has LY3437943 (Part A) been validated by the U.S Food and Drug Administration?

"Our experts have assessed LY3437943 (Part A) to be of low safety, as the Phase 1 trial has not collected ample evidence for efficacy and security."

Answered by AI

Is enrollment for this medical study still open?

"According to the details available on clinicaltrials.gov, this intervention is no longer recruiting participants after being initially posted on July 18th 2023 and most recently updated one day prior. Although this trial has been closed, there are 802 other studies still searching for volunteers at present."

Answered by AI

What are the eligibility criteria for this research endeavor?

"To be eligible for this research trial, participants must have a clean bill of health and reside between the ages of 18-70. A total of 64 subjects need to partake in the study."

Answered by AI

Does this clinical research enlist participants aged 18 and above?

"Patients eligible to take part in this medical trial must be over 18 and under 70. For those who are younger or older than that, there is a collection of 56 studies for minors and 375 studies available for elderly participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of LY3437943 in Healthy Participants With a High Body Mass Index
2023. "A Study of LY3437943 in Healthy Participants With a High Body Mass Index". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05959096.
~8 spots leftby Jul 2024
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