GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants

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

Lead sponsor

Janssen Research & Development, LLC

Assets

Efinopegdutide / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

474

actual

Study population

Obesity / overweight

Key I/E criterion

—

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 IDNCT03486392

Org study IDCR108314

Secondary ID2017-003616-39

Secondary ID64565111OBE2001Janssen Research & Development, LLC

Timeline

Milestones

Study start2018-03-26actual

Study first posted2018-04-03actual

Primary completion2019-03-08actual

Study completion2019-03-08actual

Last update posted2020-02-05actual

Results first posted2020-02-05actual

Assets

Investigational agents

Efinopegdutide Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

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 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

Exclusion criteria

•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

Endpoints (10)

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

8 endpoints

Primary/registry result

Percent Change From Baseline in Body Weight at Week 26

Time frame:Baseline, Week 26

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Double Blind: Placebo	-1.76	—
Double Blind: JNJ-64565111 5.0 mg	-8.51	—
Double Blind: JNJ-64565111 7.4 mg	-9.83	—
Double Blind: JNJ-64565111 10.0 mg	-11.80	—
Open Label: Liraglutide 3.0 mg	-7.54	—

Difference of least square (LS) Means-6.7595% CI-9.31 – -4.19p< 0.001Dunnett's method

Difference of LS Means-8.0795% CI-10.31 – -5.84p< 0.001Dunnett's method

Difference of LS Means-10.0495% CI-12.31 – -7.78p< 0.001Dunnett's method

Difference of LS Means-5.7895% CI-7.99 – -3.57p< 0.001Dunnett's method

Primary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 26

Time frame:Baseline, Week 26

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Double Blind: Placebo	8	—
Double Blind: JNJ-64565111 5.0 mg	34	—
Double Blind: JNJ-64565111 7.4 mg	70	—
Double Blind: JNJ-64565111 10.0 mg	62	—
Open Label: Liraglutide 3.0 mg	56	—

Secondary/registry result

Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Double Blind: Placebo	2	—
Double Blind: JNJ-64565111 5.0 mg	23	—
Double Blind: JNJ-64565111 7.4 mg	43	—
Double Blind: JNJ-64565111 10.0 mg	46	—
Open Label: Liraglutide 3.0 mg	27	—

Secondary/registry result

Change From Baseline in Body Weight at Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Double Blind: Placebo	-2.05	—
Double Blind: JNJ-64565111 5.0 mg	-9.58	—
Double Blind: JNJ-64565111 7.4 mg	-11.07	—
Double Blind: JNJ-64565111 10.0 mg	-13.23	—
Open Label: Liraglutide 3.0 mg	-8.32	—

Secondary/protocol endpoint

Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/registry result

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to Week 30

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Double Blind: Placebo	43	—
Double Blind: JNJ-64565111 5.0 mg	53	—
Double Blind: JNJ-64565111 7.4 mg	110	—
Double Blind: JNJ-64565111 10.0 mg	110	—
Open Label: Liraglutide 3.0 mg	96	—

Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to Week 30

Treatment-emergent AEs (any)

event count, event

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.