Current partner codePEPTIDESDE
NCT03928379·Phase 1·INTERVENTIONAL

A Study of LY3305677 in Participants With Type 2 Diabetes

Status

Completed

Phase

Phase 1

Enrollment

24

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The main purpose of this study is to learn more about the safety and side effects of LY3305677 when it is given as an injection just under the skin to participants with type 2 diabetes. The study will last about 20 weeks for each participant, not including screening.

Interventions

Treatment arms and agents.

DRUG

LY3305677

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Apr 26, 2019

  2. Study start

    Oct 27, 2019

  3. Primary completion

    Jul 8, 2021

  4. Study completion

    Jul 8, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jul 19, 2021

Outcomes

What the study measures.

Primary outcomes

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

Time frame · Baseline through 24 weeks

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677

Time frame · Baseline through 48 hours postdose

PK: Cmax of LY3305677

PK: Area Under the Concentration-Time Curve (AUC) of LY3305677

Time frame · Baseline through 48 hours postdose

PK: AUC of LY3305677

Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose

Time frame · Baseline, through Week 16

PD: Change from Baseline in Fasting Plasma Glucose

PD: Change from Baseline in Fasting Plasma Insulin

Time frame · Baseline, through Week 16

PD: Change from Baseline in Fasting Plasma Insulin

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
69 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Have Type II diabetes * Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive * Have a body weight of \<150 kilograms (kg) * Have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, CK values within the normal range at screening and Day -2. Exclusion Criteria: * Have Type 1 diabetes or latent autoimmune diabetes in adults * Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening * Have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Visit 1 * Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis * Have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening * Have an estimated glomerular filtration rate \<45 milliliters per minute per 1.73 meters squared of body surface area (mL/min/1.73 m²)

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Mazdutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.