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Clinical Trials/NCT07437079
NCT07437079RecruitingPhase 1

A First Human Dose Study Investigating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single and Multiple Ascending Doses of NNC6989-0001 in Healthy Participants With Overweight or Obesity

Novo Nordisk A/S1 site in 1 country132 target enrollmentStarted: February 24, 2026Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
132
Locations
1
Primary Endpoint
Number of treatment emergent adverse events (TEAE) - Part A
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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) and Part C (meal timing and potentially meal composition).
  • •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

  • •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.

Outcomes

Primary Outcomes

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

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

Measure in number of events.

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

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

Measured in number of events

iAUCTG; The incremental area under the blood triglycerides concentration-time curve following meal test - Part C

Time Frame: Following meal test at Day -1, Day 1, Day 7 and Day 13

Measured in ratio

Secondary Outcomes

  • 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))
  • AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part C(From pre-dose on Day 1 until completion of the end of study visit (Day 20))
  • Cmax; the maximum plasma concentration of NNC6989-0001 - Part C(From pre-dose on Day 1 until completion of the end of study visit (Day 20))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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