Phase 2
N=196
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
Obesity and Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03586830 ↗Enrolled (actual)
196
Serious AEs
3.6%
Results posted
Jan 2020
Primary outcome: Primary: Percent Change From Baseline in Body Weight at Week 12 — -0.70; -5.25; -6.55; -7.92 Percent Change — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-64565111 Dose Level 1 (Drug); JNJ-64565111 Dose Level 2 (Drug); JNJ-64565111 Dose Level 3 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight at Week 12 |
-0.70; -5.25; -6.55; -7.92 | <.001 sig |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
28; 30; 39; 36 | — |
| SECONDARY Change From Baseline in Body Weight at Week 12 |
-0.90; -5.92; -7.34; -9.04 | — |
| SECONDARY Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12 |
1; 20; 20; 30 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Body Mass Index (BMI) greater than or equal to (>=) 35 to less than or equal to ( = 6.5% and = 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 ( = 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
Data sourced from ClinicalTrials.gov (NCT03586830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.