Obesity and Diabetes Mellitus, Type 2Phase 2NCT03586830

A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus

A Phase 2 study testing JNJ-64565111 Dose Level 1, JNJ-64565111 Dose Level 2 and JNJ-64565111 Dose Level 3 in people with Obesity and Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Obesity and Diabetes Mellitus, Type 2
What is being tested?: JNJ-64565111 Dose Level 1, JNJ-64565111 Dose Level 2 and JNJ-64565111 Dose Level 3
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 196 participants
Where: 27 sitesUnited States
Study dates: 26 Jun 2018to 5 Apr 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Clinical Research Associates of Central PA, LLC
Altoona, Pennsylvania, 16602
Heritage Valley Medical Group
Beaver, Pennsylvania, 15009
Central Research Associates, Inc.
Birmingham, Alabama, 35205
Dallas Diabetes & Endocrine Center at Medical City
Dallas, Texas, 75230
Baylor Endocrine Center
Dallas, Texas, 75246
Spectrum Medical, Inc
Danville, Virginia, 24541
AAMRC
Flint, Michigan, 48504
Prestige Clinical Research
Franklin, Ohio, 45005
Alas Science Clinical Research
Henderson, Nevada, 89014
National Research Institute
Los Angeles, California, 90057
Albert J. Weisbrot and Associates
Mason, Ohio, 45040
Clinical Research Institute of Southern Oregon, P.C.
Medford, Oregon, 97504
Premeir Clinical Research Institute
Miami, Florida, 33122
International Research Associates, LLC
Miami, Florida, 33183
Clinical Research Associates Inc
Nashville, Tennessee, 37203
Permian Research Foundation
Odessa, Texas, 79761
CNS HealthCare
Orlando, Florida, 32801
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
M.D. Medical Research
Oxon Hill, Maryland, 20745
Rancho Cucamonga Clinical Trials
Rancho Cucamonga, California, 91730
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219
National Clinical Research
Richmond, Virginia, 23294
Sierra Clinical Research
Roseville, California, 95661
Encompass Clinical Research
Spring Valley, California, 91978
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606
Buynak Clinical Research
Valparaiso, Indiana, 46383
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598

Other trials in United States

About this study

Official 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

Conditions: Obesity and Diabetes Mellitus, Type 2
Being tested: JNJ-64565111 Dose Level 1, JNJ-64565111 Dose Level 2, JNJ-64565111 Dose Level 3, Placebo
Medical subject headings: Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JNJ-64565111 Dose Level 1Drug
Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
JNJ-64565111 Dose Level 2Drug
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.
JNJ-64565111 Dose Level 3Drug
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.
PlaceboDrug
Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.

Study groups in NCT03586830
Study group	Role	What they receive
JNJ-64565111 Dose Level 1	Experimental	Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase. Receives: Drug: JNJ-64565111 Dose Level 1
JNJ-64565111 Dose Level 2	Experimental	Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase. Receives: Drug: JNJ-64565111 Dose Level 2
JNJ-64565111 Dose Level 3	Experimental	Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase. Receives: Drug: JNJ-64565111 Dose Level 3
Placebo	Placebo comparator	Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Body Weight at Week 12
Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.
Measured: Baseline, Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to 16 Weeks

Secondary outcomes (2)

Change From Baseline in Body Weight at Week 12
Change from baseline in body weight at Week 12 was reported.
Measured: Baseline, Week 12
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12
Number of participants with >= 5 % weight loss at Week 12 was reported.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 20185 Apr 2019

First posted16 Jul 2018
Study start26 Jun 2018
Primary completion5 Apr 2019
Study completion5 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obesity and Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03586830
Sponsor's protocol ID: CR108488
Other IDs: 64565111OBE2002
Status last verified: Dec 2019
First submitted: 22 Jun 2018
Last updated: 7 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03586830
Acronym / sponsor ID: CR108488
Conditions: Obesity and Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 26 Jun 2018 (actual)
Primary completion: 5 Apr 2019 (actual)
Study completion: 5 Apr 2019 (actual)
First posted: 16 Jul 2018 (actual)
Results: Posted 7 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
JNJ-64565111 Dose Level 1	Experimental	Drug: JNJ-64565111 Dose Level 1Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase.
JNJ-64565111 Dose Level 2	Experimental	Drug: JNJ-64565111 Dose Level 2Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase.
JNJ-64565111 Dose Level 3	Experimental	Drug: JNJ-64565111 Dose Level 3Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JNJ-64565111 Dose Level 1Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.	Drug	JNJ-64565111 Dose Level 1
JNJ-64565111 Dose Level 2Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.	Drug	JNJ-64565111 Dose Level 2
JNJ-64565111 Dose Level 3Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.	Drug	JNJ-64565111 Dose Level 3
PlaceboParticipants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.	Drug	Placebo

Primary outcome

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.
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.

2 secondary outcomes

Change From Baseline in Body Weight at Week 12
Time frame: Baseline, Week 12
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 7 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	50	48
JNJ-64565111 5.0 mg	48	42
JNJ-64565111 7.4 mg	49	41
JNJ-64565111 10.0 mg	49	44

Primary outcome: Percent Change From Baseline in Body Weight at Week 12

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: Percent Change

Measure	Placebo n = 49	JNJ-64565111 5.0 mg n = 45	JNJ-64565111 7.4 mg n = 46	JNJ-64565111 10.0 mg n = 47
Value	-0.70 (0.50)	-5.25 (0.57)	-6.55 (0.56)	-7.92 (0.55)

Placebo vs JNJ-64565111 5.0 mg: Difference of least square (LS) means: -4.56 (95% CI -6.05 to -3.06), p <.001, Hochberg Approach
Placebo vs JNJ-64565111 7.4 mg: Difference of LS Means: -5.85 (95% CI -7.34 to -4.36), p <.001, Hochberg Approach
Placebo vs JNJ-64565111 10.0 mg: Difference of LS Means: -7.23 (95% CI -8.70 to -5.75), p <.001, Hochberg Approach

Population analysed: Modified intent-to-treat (mITT) analysis set included all intent-to-treat (ITT) participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to 16 Weeks. Count of participants. Unit: Participants

Measure	Placebo n = 49	JNJ-64565111 5.0 mg n = 48	JNJ-64565111 7.4 mg n = 49	JNJ-64565111 10.0 mg n = 49
Value	28	30	39	36

Population analysed: Safety analysis set included include all randomized participants who had received at least one dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 16 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 49 (2%)	18 of 49 (36.7%)	0 of 49
JNJ-64565111 5.0 mg	2 of 48 (4.2%)	25 of 48 (52.1%)	0 of 48
JNJ-64565111 7.4 mg	1 of 49 (2%)	33 of 49 (67.3%)	0 of 49
JNJ-64565111 10.0 mg	3 of 49 (6.1%)	30 of 49 (61.2%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight at Week 12 (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03586830.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.