GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT06719011

RecruitingPhase 1

A Study on How NNC0174-1213 Works in People With Overweight or Obesity.

A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.

Lead sponsor

Novo Nordisk A/S

Asset

CagriSema / cagrilintide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

Enrollment

177

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI 27-34.9•Male

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 IDNCT06719011

Org study IDNN9839-8082

Secondary IDU1111-1308-5620World Health Organization (WHO)

Timeline

Milestones

Study start2024-12-03actual

Study first posted2024-12-05actual

Last update posted2025-05-25actual

Primary completion2026-03-26estimated

Study completion2026-05-17estimated

Assets

Investigational agents

CagriSema / cagrilintide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Male.

•Age 18-55 years (both inclusive) at the time of signing the informed consent.

•Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

•Body weight more than or equal to (>=) 80.0 kilograms (kg) at screening.

•Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

•Known or suspected hypersensitivity to study intervention(s) or related products.

•Exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.

•Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.

•Impaired liver function defined as any of the below:

•Aspartate aminotransferase (AST) more than or equal to (>=) 2 times upper limit of normal at screening

•Alanine aminotransferase (ALT) more than or equal to (>=) 2 times upper limit of normal at screening

•Bilirubin more than (>) 1.5 times upper limit of normal at screening (except if known or proven Gilbert's syndrome)

•Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (<) 75 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at screening.

•Glycated haemoglobin (HbA1c) more than or equal to (>=) 6.5 percent (%) (48 millimoles per mole (mmol/mol) at screening.

•Any clinically significant body weight change more than or equal to (>=) 5 percent (%) self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening .

•Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.

•Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:

•Vitamin D (25-hydroxycholecalciferol) less than (<) 12 nanogram per milliliter (ng/mL) (30 nanometer (nM) at screening

•Parathyroid hormone (PTH) outside normal range at screening

•Total calcium outside normal range at screening

•Calcitonin more than or equal to (>=) 50 nanogram per liter (ng/L) at screening

Endpoints (6)

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.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213

Time frame:From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Part B: Number of treatment emergent adverse events (TEAE)

Time frame:From first administration (Day 1) to completion of the end of study visit (Day 67)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve

Time frame:From pre-dose on Day 1 to completion of the end of study visit (Day 46)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part A: Cmax; maximum observed NNC0174 1213 plasma concentration

Time frame:From pre-dose on Day 1 to completion of the end of study visit (Day 46)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve

Time frame:From first administration (Day 1) to completion of the end of study visit (Day 67)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part B: Cmax; maximum observed NNC0174 1213 plasma concentration

Time frame:From first administration (Day 1) to completion of the end of study visit (Day 67)

Cmax

concentration, 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.