Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07437079

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionOverweight, Obesity

Full registry criteria

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.

Treatments and study arms

NNC6989-0001

Drug

Participants assigned to the active intervention receive NNC6989-0001

Placebo (NNC6989-0001)

Drug

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

Primary outcomes

Number of treatment emergent adverse events (TEAE) - Part AFrom 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 BFrom 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 CFollowing meal test at Day -1, Day 1, Day 7 and Day 13

Measured in ratio

Study locations

1 locations were listed when this page was built. The first 40 are shown.

ICON Early Phase Services, LLC🇺🇸 Lenexa, Kansas, United States