A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus
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Keep this study
Lead
Janssen Research & Development, LLC
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of type 2 diabetes mellitus (T2DM) at least 3 months prior to Screening
Hemoglobin A1c (HbA1c) greater than or equal to (\>=) 7.0 percent (%) and lesser than or equal to (\<=)9.5% at Screening
On a stable treatment regimen for at least 3 months prior to Screening of (1) diet and exercise, and/or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg) per day)
Body mass index (BMI) ranging from 25 to 40 kilogram per square meter (kg/m\^2) (inclusive), weighing between 75 and 130 kg (inclusive)
A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hCG) at Screening and Day -2
Blood pressure (measured after the participant is sitting/ resting quietly for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 60 and 100 mmHg diastolic, inclusive at Screening (sitting) and Day -2 (supine). If the average of the first triplicate blood pressure assessment is out of range, up to 2 repeated triplicate assessments are permitted
You may not be if
History or current diagnosis of acute or chronic pancreatitis
Familial or personal history of multiple endocrine neoplasia type 2,familial/non-familial medullary thyroid carcinoma
Donated blood or blood products or lost a significant amount of blood (\>500 milliliter \[mL\]) within 3 months before the first administration of study drug
History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
Clareo Health | A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus
