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Monoclonal Antibodies

LY3938577 for Type 2 Diabetes

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
Male or female participants of nonchildbearing potential
Have a body mass index within the range of 18.5 to less than or equal to (<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for T2DM participants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: predose up to 16 days and part b: predose up to 44 days
Awards & highlights

Study Summary

This trial tests the safety and effectiveness of a drug for people with Type 2 Diabetes Mellitus, lasting 6-10 weeks.

Who is the study for?
This trial is for healthy adults and those with Type 2 Diabetes Mellitus (T2DM). Healthy participants should have a BMI of 18.5-32 kg/m², while T2DM participants can have up to 40 kg/m². T2DM should be diagnosed over a year ago. People with severe eye or nerve complications, recent steroid therapy, or participation in another study recently cannot join.Check my eligibility
What is being tested?
The safety and tolerability of LY3938577 are being tested on two groups: healthy individuals and those with T2DM. Part A involves a single dose for both types of participants; Part B gives multiple doses to only the T2DM group. The study compares LY3938577 against Insulin degludec and placebo over approximately six to ten weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from diabetes medications may include low blood sugar levels, weight gain, nausea, injection site reactions, headache, upper respiratory tract infections and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I cannot become pregnant or get someone pregnant.
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My BMI is within the required range for my health status.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: predose up to 16 days and part b: predose up to 44 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: predose up to 16 days and part b: predose up to 44 days 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: Incidence of Hypoglycemia
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
+5 more
Secondary outcome measures
Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: LY3938577 (Part B)Experimental Treatment1 Intervention
LY3938577 administered SC.
Group II: LY3938577 (Part A)Experimental Treatment1 Intervention
LY3938577 administered Subcutaneously (SC).
Group III: Insulin degludec (Part A)Active Control1 Intervention
Insulin degludec administered SC.
Group IV: Insulin degludec (Part B)Active Control1 Intervention
Insulin degludec administered SC.
Group V: Placebo (Part A)Placebo Group1 Intervention
Placebo administered SC.

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
2,624 Previous Clinical Trials
3,216,936 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,794 Total Patients Enrolled

Frequently Asked Questions

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

What perils are associated with using LY3938577 (Part A) in patients?

"As this is a phase 1 trial, and there is only minimal evidence to support its safety and efficacy, the team at Power have assigned LY3938577 (Part A) a score of 1 on their risk scale."

Answered by AI

Is it possible to register for this medical trial?

"Eligible participants should be between 18-70 years old and in good health. Currently, 88 people are being sought for the trial."

Answered by AI

Does this clinical trial encompass geriatric patients?

"This research team is seeking participants of legal age (18+) and under 70 years old."

Answered by AI

Are participants being admitted to this research endeavor at present?

"Unfortunately, this clinical trial is not actively soliciting participants. Initially posted on November 17th 2023 and updated for the last time on November 10th 2023, it has already reached its recruitment quota of participants. However, there are 2330 other trials that offer potential candidates the opportunity to participate in medical research right now."

Answered by AI

What is the prevalence of this research effort in our urban area?

"Qps-Mra, Llc in Miami, Labcorp CRU in Dallas, and Endeavor Clinical Trials in San Antonio are some of the 4 active recruitment sites for this trial. In addition to those locations, there exists a further quartet of clinical centres that are participating."

Answered by AI

Who else is applying?

What site did they apply to?
CenExel ACT
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
2023. "A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132126.
~22 spots leftby Aug 2024
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