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Completed

NCT Number: NCT03586830

A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central Research Associates, Inc., Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-64565111 Dose Level 1

Drug

Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.

JNJ-64565111 Dose Level 2

Drug

Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.

JNJ-64565111 Dose Level 3

Drug

Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.

Placebo

Drug

Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 12

    Time frame: Baseline, Week 12

    Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 16 Weeks

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An TEAE is defined as an AE with an onset after the initiation study medication and before the last study medication date of the double-blind (12-Week) treatment phase plus 35 Days.

Secondary outcomes

  1. Change From Baseline in Body Weight at Week 12

    Time frame: Baseline, Week 12

    Change from baseline in body weight at Week 12 was reported.

  2. Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12

    Time frame: Week 12

    Number of participants with >= 5 % weight loss at Week 12 was reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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