GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

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

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

Lead sponsor

Janssen Research & Development, LLC

Asset

Efinopegdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

196

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-9.5%

Primary endpoints

•Body weight, % change•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03586830

Org study IDCR108488

Secondary ID64565111OBE2002Janssen Research & Development, LLC

Timeline

Milestones

Study start2018-06-26actual

Study first posted2018-07-16actual

Primary completion2019-04-05actual

Study completion2019-04-05actual

Last update posted2020-01-07actual

Results first posted2020-01-07actual

Assets

Investigational agents

Efinopegdutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

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 (<) 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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Safety / tolerability / PK

Weight & body composition

3 endpoints

Primary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 12

Time frame:Baseline, Week 12

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Placebo	-0.70	—
JNJ-64565111 5.0 mg	-5.25	—
JNJ-64565111 7.4 mg	-6.55	—
JNJ-64565111 10.0 mg	-7.92	—

Difference of least square (LS) means-4.5695% CI-6.05 – -3.06p<.001Hochberg Approach

Difference of LS Means-5.8595% CI-7.34 – -4.36p<.001Hochberg Approach

Difference of LS Means-7.2395% CI-8.70 – -5.75p<.001Hochberg Approach

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 12

Time frame:Baseline, Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Placebo	-0.90	—
JNJ-64565111 5.0 mg	-5.92	—
JNJ-64565111 7.4 mg	-7.34	—
JNJ-64565111 10.0 mg	-9.04	—

Secondary/protocol endpoint

Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12

Time frame:Week 12

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	1	—
JNJ-64565111 5.0 mg	20	—
JNJ-64565111 7.4 mg	20	—
JNJ-64565111 10.0 mg	30	—

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to 16 Weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	28	—
JNJ-64565111 5.0 mg	30	—
JNJ-64565111 7.4 mg	39	—
JNJ-64565111 10.0 mg	36	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Psychometric evaluation of the DAILY EATS questionnaire in individuals living with obesity.
Journal of patient-reported outcomes2020 Nov 23PMID33226548doi:10.1186/s41687-020-00259-wvia pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.