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CompletedPhase 1

Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity

A Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

187

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 25-39.9

Primary endpoint

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 IDNCT02870231
Org study IDNN9030-4130
Secondary IDU1111-1175-7040WHO

Timeline

Milestones

Study first posted2016-08-17estimated
Study start2016-08-18actual
Primary completion2017-09-03actual
Study completion2017-09-03actual
Last update posted2018-09-05actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.
Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent

Exclusion criteria

Any clinically significant weight change (equal or above 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program within the last 90 days prior to screening
Any prior obesity surgery or currently present gastrointestinal implant.
Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
Calcitonin above or equal to 50 ng/L
History of pancreatitis (acute or chronic)

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

Safety / tolerability / PK
3
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in HbA1C

Time frame:Day -1, Day 85

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Number of treatment emergent adverse events

Time frame:Day 1-112

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Area under the NNC9204-0530 serum concentration-time curve

Time frame:Day 84-112

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to maximum serum concentration of NNC9204-0530

Time frame:Day 84-112

Tmax

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.