ObesityPhase 2NCT03486392
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
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, run by Janssen Research & Development, LLC at 51 sites in 6 countries.
Trial summary
The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- 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
- 474 participants
- Where
- 51 sitesin 6 countries
- Study dates
- 26 Mar 2018to 8 Mar 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 square meter (kg/m^2) at the screening visit
- Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical history)
- 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
- Woman of childbearing potential have a negative pregnancy test at screening
- Willing and able to adhere to specific the prohibitions and restrictions
Who cannot join
- History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)
- History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Has a Hemoglobin A1c (HbA1c) of >= 6.5% or fasting plasma glucose (FPG) >= 126 milligrams per deciliter (mg/dL) (>= 7.0 millimoles per liter [mmol/L]) at screening
- Screening calcitonin of >= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening
- History of glucagonoma
Trial locations and contacts
51 sites in 6 countries.
51 sites in 6 countries
United States17 sites
Advanced Clinical Research
Boise, Idaho, 83642
Rapid Medical Research
Cleveland, Ohio, 44122
Dallas Diabetes Research Center
Dallas, Texas, 75230
Medisphere Medical Research Center, Llc
Evansville, Indiana, 47714
Care Partners Clinical Research
Jacksonville, Florida, 32277
L-Marc Research Center
Louisville, Kentucky, 40213
Central New York Clinical Research
Manlius, New York, 13104
Milford Emergency Associates, Inc.
Marlborough, Massachusetts, 01752
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Weill Cornell Medicine
New York, New York, 10065
Permian Research Foundation
Odessa, Texas, 79761
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020
Rainier Clinical Research Center
Renton, Washington, 98057
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Omega Medical Research
Warwick, Rhode Island, 02886
Allegiance Reserach Specialists, LLC
Wauwatosa, Wisconsin, 53226
Advanced Clinical Research
West Jordan, Utah, 84088
Belgium8 sites
OLV Ziekenhuis Aalst
Aalst, 9300
CSL Arlon
Arlon, 6700
UZ Antwerpen
Edegem, 2650
UZ Leuven
Leuven, 3000
CHU de Liège
Liège, 4000
AZ Delta
Roeselare, 8800
AZ Glorieux Ronse
Ronse, 9600
Practimed Medical Center
Tessenderlo, 3980
Canada7 sites
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, N1R 7L6
Manna Research
Lévis, Quebec, G6W 0M5
Manna Research
Pointe-Claire, Quebec, H9R 4S3
Clinique des Maladies Lipidiques de Québec
Québec, Quebec, G1V 4W2
Canadian Phase Onward
Toronto, Ontario, M3J 2C5
Dr. Anil K Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
Manna Research
Toronto, Ontario, M9W 4L6
Sweden7 sites
Katarina Berndtsson-Blom Ladulaaskliniken
Borås, 50630
Intern Medicin
Gothenburg, 41345
PTC,Primary care Trial Center
Gothenburg, 42144
PharmaSite
Helsingborg, 25220
PharmaSite
Malmö, 21152
Avdelningen för kliniska prövningar
Örebro, 701 85
PTC- Skaraborg
Skövde, 541 50
United Kingdom7 sites
Southmead Hospital
Bristol, BS10 5NB
Ashgate Medical Practice
Chesterfield, S40 4AA
Hathaway Medical Centre
Chippenham, SN14 6GT
Aintree University Hospital NHS Trust
Liverpool, L9 7AL
Clifton Medical Centre
Rotherham, S65 1DA
Albany House Medical Centre
Wellingborough, NN8 4RW
Bradford on Avon and Melksham Health Partnership
Wiltshire, BA15 1DQ
Poland5 sites
Indywidualna Praktyka Lekarska, Gabinet Leczenia Otyłości i Chorób Dietozależnych
Bialystok, 15-281
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
NZOZ 'Linia' Centrum Leczenia Zaburzeń Metabolicznych Magdalena Olszanecka-Glinianowicz
Katowice, 40-767
Nzoz Salvia
Katowice-Ligota, 40-752
Centrum Zdrowia Metabolicznego Paweł Bogdański
Poznan, 60-589
About this study
Official title: A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects
The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.
- Conditions
- Obesity
- Being tested
- JNJ-64565111 Dose Level 1, JNJ-64565111 Dose Level 2, JNJ-64565111 Dose Level 3, Liraglutide, Placebo
- Medical subject headings
- Obesity
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 26.
JNJ-64565111 Dose Level 2Drug
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
JNJ-64565111 Dose Level 3Drug
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
LiraglutideDrug
Also called Saxenda
Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.
PlaceboDrug
Participants will receive matching placebo SC once-weekly until Week 26.
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind: JNJ-64565111 Dose Level 1 | Experimental | Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase. Receives: Drug: JNJ-64565111 Dose Level 1 |
| Double-Blind: JNJ-64565111 Dose Level 2 | Experimental | Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase. Receives: Drug: JNJ-64565111 Dose Level 2 |
| Double-Blind: JNJ-64565111 Dose Level 3 | Experimental | Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase. Receives: Drug: JNJ-64565111 Dose Level 3 |
| Double-Blind: Placebo | Placebo comparator | Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase. Receives: Drug: Placebo |
| Open-Label: 3.0 milligram (mg) Liraglutide | Active comparator | Participant will receive once-daily doses of 0.6, 1.2, 1.8, 2.4, or 3.0 mg. The participants will receive liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1. Participants will be instructed to increase the dose of liraglutide by 0.6 mg dose increment every 7 days, up to the full dosage of 3.0 mg by Week 5. Participants will then continue on the 3.0 mg once-daily dosage until Week 26. Receives: Drug: Liraglutide |
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 26
Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
Measured: Baseline, Week 26
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. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.
Measured: Up to Week 30
Secondary outcomes (3)
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
Number of participants with >= 5% body weight loss from baseline to Week 26 were reported.
Measured: Week 26
Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26
Number of participants with >= 10 % body weight loss from baseline to Week 26 were reported.
Measured: Week 26
Change From Baseline in Body Weight at Week 26
Change from baseline in body weight at Week 26 was reported.
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start26 Mar 2018
- Primary completion8 Mar 2019
- Study completion8 Mar 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 ObesityStudies 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
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486392
- Sponsor's protocol ID
- CR108314
- Other IDs
- 64565111OBE2001, 2017-003616-39, 2017
- Status last verified
- Jan 2020
- First submitted
- 23 Mar 2018
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects
- ClinicalTrials.gov ID
- NCT03486392
- Acronym / sponsor ID
- CR108314
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Double-Blind: JNJ-64565111 Dose Level 1 | Experimental | Drug: JNJ-64565111 Dose Level 1Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase. |
| Double-Blind: JNJ-64565111 Dose Level 2 | Experimental | Drug: JNJ-64565111 Dose Level 2Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase. |
| Double-Blind: JNJ-64565111 Dose Level 3 | Experimental | Drug: JNJ-64565111 Dose Level 3Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase. |
| Double-Blind: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase. |
| Open-Label: 3.0 milligram (mg) Liraglutide | Active comparator | Drug: LiraglutideParticipant will receive once-daily doses of 0.6, 1.2, 1.8, 2.4, or 3.0 mg. The participants will receive liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1. Participants will be instructed to increase the dose of liraglutide by 0.6 mg dose increment every 7 days, up to the full dosage of 3.0 mg by Week 5. Participants will then continue on the 3.0 mg once-daily dosage until Week 26. |
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 square meter (kg/m^2) at the screening visit
- Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical history)
- 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
- Woman of childbearing potential have a negative pregnancy test at screening
- Willing and able to adhere to specific the prohibitions and restrictions
Key exclusion criteria (5 listed)
- History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)
- History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Has a Hemoglobin A1c (HbA1c) of >= 6.5% or fasting plasma glucose (FPG) >= 126 milligrams per deciliter (mg/dL) (>= 7.0 millimoles per liter [mmol/L]) at screening
- Screening calcitonin of >= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening
- History of glucagonoma
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 26. | Drug | Double-Blind: JNJ-64565111 Dose Level 1 |
| JNJ-64565111 Dose Level 2Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26. | Drug | Double-Blind: JNJ-64565111 Dose Level 2 |
| JNJ-64565111 Dose Level 3Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26. | Drug | Double-Blind: JNJ-64565111 Dose Level 3 |
| LiraglutideAlso: SaxendaParticipants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26. | Drug | Open-Label: 3.0 milligram (mg) Liraglutide |
| PlaceboParticipants will receive matching placebo SC once-weekly until Week 26. | Drug | Double-Blind: Placebo |
Primary outcome
Percent Change From Baseline in Body Weight at Week 26
Time frame: Baseline, Week 26
Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 30
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. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.
3 secondary outcomes
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
Time frame: Week 26
Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26
Time frame: Week 26
Change From Baseline in Body Weight at Week 26
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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
51 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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, run by Janssen Research & Development, LLC at 51 sites in 6 countries.
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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Belgium, Canada, Sweden, United Kingdom and 1 more country. 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 5 Feb 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 26 (time frame: Baseline, Week 26). 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?
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 5 Feb 2020.