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 |
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.
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
sites
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