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

NCT06719011 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN9839-8082U1111-1308-5620
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

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

  Number of events

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

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

  Number of events

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

Secondary Outcomes (4)

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

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

• Part A: Cmax; maximum observed NNC0174 1213 plasma concentration

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

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

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

• Part B: Cmax; maximum observed NNC0174 1213 plasma concentration

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

Study Arms (6)

Part A: NNC0174-1213 (SD1-SD5)

EXPERIMENTAL

Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.

Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A)

Part A: Cagrilintide (SDA and SDB)

EXPERIMENTAL

Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4.

Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A)

Part A: Placebo

EXPERIMENTAL

Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.

Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A)

Part B: NNC0174-1213 (MD1-MD5)

EXPERIMENTAL

Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.

Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A)

Part B: Cagrilintide (MDA)

EXPERIMENTAL

Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.

Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A)

Part B: Placebo

EXPERIMENTAL

Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.

Drug: NNC0174-1213 A; Drug: Cagrilintide B; Drug: Placebo A (NNC0174 1213 A)

Interventions

NNC0174-1213 A DRUG

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.

Part A: Cagrilintide (SDA and SDB); Part A: NNC0174-1213 (SD1-SD5); Part A: Placebo; Part B: Cagrilintide (MDA); Part B: NNC0174-1213 (MD1-MD5); Part B: Placebo

Cagrilintide B DRUG

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.

Part A: Cagrilintide (SDA and SDB); Part A: NNC0174-1213 (SD1-SD5); Part A: Placebo; Part B: Cagrilintide (MDA); Part B: NNC0174-1213 (MD1-MD5); Part B: Placebo

Placebo A (NNC0174 1213 A) DRUG

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.

Part A: Cagrilintide (SDA and SDB); Part A: NNC0174-1213 (SD1-SD5); Part A: Placebo; Part B: Cagrilintide (MDA); Part B: NNC0174-1213 (MD1-MD5); Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

RECRUITING

ICON Early Phase Services, LLC

Salt Lake City, Utah, 84124, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 3, 2024
• Primary Completion: March 26, 2026
• Study Completion: May 17, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)