Current partner codePEPTIDESDE
NCT06719011·Phase 1·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 1

Enrollment

177

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.

Interventions

Treatment arms and agents.

DRUG

NNC0174-1213 A

Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

DRUG

Cagrilintide B

Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

DRUG

Placebo A (NNC0174 1213 A)

Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

Timeline

From registration to results.

  1. First posted

    Dec 5, 2024

  2. Study start

    Dec 3, 2024

  3. Primary completion

    Mar 26, 2026

  4. Study completion

    May 17, 2026

  5. Results posted

    Not reported

  6. Registry updated

    May 25, 2025

Outcomes

What the study measures.

Primary outcomes

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)

Number of events

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)

Number of events

Secondary outcomes

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)

measured in hour\*nanomoles per liter (h\*nmol/L).

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)

measured in nanomoles per liter (nmol/L).

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)

measured in h\*nmol/L.

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)

measured in nmol/L.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
MALE
Healthy volunteers
No

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

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

ICON Early Phase Services, LLC

San Antonio, Texas, United States

ICON Early Phase Services, LLC

Salt Lake City, Utah, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cagrilintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.