A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:3/10/2019
Start Date:June 26, 2018
End Date:April 4, 2019

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A Randomized, Double-blind Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in
severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on:
the percentage change in body weight from baseline and safety and tolerability.


Inclusion Criteria:

- Body Mass Index (BMI) greater than or equal to (>=) 35 to less than or equal to (<=)
50 kilogram per meter square (kg/m^2) at screening

- Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening
based on medical or participant reported history)

- Hemoglobin A1c of >= 6.5% and <= 9.5% at screening and meets one of the inclusion
criteria as: (a) on diet and exercise alone >= 12 weeks prior to screening; (b) on
stable dose of single oral antihyperglycemic agent (AHA) or dual-combination oral AHAs
for >= 12 weeks prior to screening

- Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise
be incapable of pregnancy, or (c) Heterosexually active and practicing a highly
effective method of birth control, or (d) Not heterosexually active

- Willing and able to adhere to specific the prohibitions and restrictions

Exclusion Criteria:

- History of obesity with a known secondary cause (example, Cushing's disease/syndrome)

- History of Type 1 diabetes mellitus, diabetic ketoacidosis, pancreas or beta-cell
transplantation, or diabetes secondary to pancreatitis or pancreatectomy

- Fasting C-peptide less than (<) 0.7 nanogram per milliliter (ng/mL) at screening

- Fasting fingerstick glucose of >= 270 milligram per deciliter (mg/dL) (>=15 millimoles
per liter [mmol/L]) on Day 1

- Ongoing, inadequately controlled thyroid disorder as assessed by the investigator's
review of the participant's medical history. Participants taking thyroid hormone
replacement therapy must be on stable doses for at least 6 weeks before the screening
visit
We found this trial at
27
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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8200 SW 117th Ave # 210
Miami, Florida 33183
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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Altoona, Pennsylvania 16602
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Beaver, Pennsylvania 15009
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Birmingham, Alabama 35205
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Dallas, Texas 75246
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Danville, Virginia 24541
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Flint, Michigan 48504
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Franklin, Ohio 45005
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Henderson, Nevada 89014
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Nashville, Tennessee 37203
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Orlando, Florida 32806
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Oxon Hill, Maryland 20745
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Rancho Cucamonga, California 91730
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Richmond, Virginia 23219
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Richmond, Virginia 23294
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Roseville, California 95661
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Spring Valley, California 91978
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55 University Drive
Valparaiso, Indiana 46383
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Walnut creek, California 94598
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