A Study to See How Safe a New Medicine (NNC6989-0001) is in Healthy People Living With Overweight or Obesity

NCT07437079 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN6989-8611U1111-1326-7700
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be decided by chance.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Number of treatment emergent adverse events (TEAE) - Part A

  Measure in number of events.

  From time of dosing on Day1 until completion of the end of study visit (Day 7)

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

  Measured in number of events

  From time of dosing on Day 1 until completion of the end of study visit (Day 14)

Secondary Outcomes (4)

• AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A

  From pre-dose on Day 1 until completion of the end of study visit (Day 7)

• Cmax; the maximum plasma concentration of NNC6989-0001 - Part A

  From pre-dose on Day 1 until completion of the end of study visit (Day 7)

• AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B

  From pre-dose on Day 1 until completion of the end of study visit (Day 14)

• Cmax; the maximum plasma concentration of NNC6989-0001 - Part B

  From pre-dose on Day 1 until completion of the end of study visit (Day 14)

Study Arms (2)

NNC6989-0001

EXPERIMENTAL

Participants receive the investigational drug NNC6989-0001

Drug: NNC6989-0001 A

Placebo

PLACEBO COMPARATOR

Participants receive placebo matched in appearance to the active drug.

Drug: Placebo (NNC6989-0001 A)

Interventions

NNC6989-0001 A DRUG

Participants assigned to the active intervention receive NNC6989-0001 A

NNC6989-0001

Placebo (NNC6989-0001 A) DRUG

Participants assigned to the placebo, receive placebo matched in appearance to the active drug.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female of non-childbearing potential.
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m\^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m\^2 for Part B (MAD part).
• 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:

• Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
• Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
• Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON Early Phase Services, LLC

Lenexa, Kansas, 66219, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): January 21, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)