Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Type 2 Diabetes Mellitus (T2DM)

NCT02862431 | Terminated Phase 1

• 3 other identifiers: CR10816664565111EDI10012016-001084-37
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of JNJ-64565111 in adult Men and Women (of non-child bearing potential) with Type 2 Diabetes Mellitus.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to Day 72

Secondary Outcomes (24)

• Number of Participants With Incidence of Anti-JNJ-64565111 Antibodies as Measure of Immunogenicity

  Up to Day 72

• Change From Baseline in Body Weight

  Baseline, up to Day 72

• Maximum Observed Plasma Concentration (Cmax)

  Up to Day 72

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Up to Day 72

• Area Under Concentration from time zero to the last quantifiable concentration AUC(0-last)

  Up to Day 72

Study Arms (4)

Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo)

EXPERIMENTAL

Participants in ratio of 3:1 will receive 2.5 Nanomole Per Kilogram (nmol/kg) JNJ-64565111 or placebo.

Drug: JNJ-64565111; Drug: Placebo

Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo)

EXPERIMENTAL

Participants in ratio of 3:1 will receive 3.0 nmol/kg JNJ-64565111 or placebo. Dose may be escalated based on review by Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29 but dose will not exceed 3.5 nmol/kg.

Drug: JNJ-64565111; Drug: Placebo

Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo)

EXPERIMENTAL

Participants in ratio of 3:1 will receive 3.5 nmol/kg JNJ-64565111 or placebo. Dose may be escalated based on review by Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29 but dose will not exceed 3.5 nmol/kg.

Drug: JNJ-64565111; Drug: Placebo

Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)

EXPERIMENTAL

Participants in ratio of 3:1 will receive a dose of JNJ-64565111 or placebo that would be a repeat or lower dose level previously assessed as well-tolerated.

Drug: JNJ-64565111; Drug: Placebo

Interventions

JNJ-64565111 DRUG

Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.

Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo); Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo); Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo); Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)

Placebo DRUG

Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.

Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo); Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo); Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo); Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Type 2 Diabetes Mellitus (T2DM) at least 3 months prior to Screening
• On a stable treatment regimen at least 3 months prior to Screening of (1) diet and exercise, or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg) per day)
• Blood pressure 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 blood pressure is out of range, up to 2 repeated assessments are permitted
• HbA1c greater than or equal to 6.5% and less than 8.5% at Screening
• Females of non-childbearing potential

You may not qualify if:

• History of, or currently active, significant illness or medical disorders, including cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), hematological disease (example, von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders, neoplastic disease, skin disorder, renal disorder, or any other illness that the Principal Investigator (PI) considers should exclude the participant or that could interfere with the interpretation of the study results
• Previous surgical treatment for obesity (example, gastric bypass, gastric banding)
• History of diabetic neuropathy with signs of gastroparesis and/or known proliferative retinopathy or maculopathy
• History or current diagnosis of acute or chronic pancreatitis
• History of an invasive cardiovascular surgical procedure including, but not limited to, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Neuss, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: August 11, 2016
• Study Start: July 12, 2016
• Primary Completion: November 29, 2016
• Study Completion: December 5, 2016
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

DE (1)