A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus

NCT03235219 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10833964565111EDI1002
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this Phase 1b 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

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to Day 72

Secondary Outcomes (28)

• Maximum Observed Serum Concentration (Cmax)

  First Dose: Predose (Day 1), and at 8, 24, 48, 72 and 120 hours post-dose (PD); Fourth Dose: predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD.

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  First Dose: Predose (Day 1), and at 8, 24, 48, 72 and 120 hours post-dose (PD); Fourth Dose: predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

• Area Under Concentration-Time Curve From Time Zero to the Last Quantifiable Time (AUC [0-last])

  First Dose: Predose (Day 1), and at 8, 24, 48, 72 and 120 hours post-dose (PD)

• Average Concentration Over the Dosing Interval Tau (T) at Steady State (Caverage,ss)

  Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

• Minimum Observed Serum Concentration (Cmin)

  Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

Study Arms (2)

Cohort 1 to 4: JNJ-64565111 or Placebo

EXPERIMENTAL

Participants in cohort 1 to 4 in a ratio of 4:1 will receive a dose of JNJ-64565111 or placebo subcutaneously on Days 1, 8, 15 and 22. Cohort 1, 2 and 3 will be dosed in parallel. Dosing for subsequent cohort 4 will be escalated based on review by the Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29, but will not exceed from well-tolerated dose.

Drug: JNJ-64565111; Drug: Placebo

Cohort 5: JNJ-64565111 (Repeat or Lower Dose) or Placebo

EXPERIMENTAL

Participants in ratio of 4:1 will receive a dose of JNJ-64565111 or placebo subcutaneously on Days 1, 8, 15 and 22, and may be modified. The dose can be repeated or lower than a dose 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.

Also known as: Oxyntomodulin

Cohort 1 to 4: JNJ-64565111 or Placebo; Cohort 5: 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 to 4: JNJ-64565111 or Placebo; Cohort 5: 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
• 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 qualify 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

ProSciento, Inc.

Chula Vista, California, 91911, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Oxyntomodulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: August 1, 2017
• Primary Completion: February 19, 2018
• Study Completion: February 19, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (2)