Safety testing of NNC6989-0001 in adults with overweight or obesity

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

This study will test whether the medicine NNC6989-0001 is safe and tolerable for adults who are overweight or have obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Lenexa, Kansas)
• Trial ID: NCT07437079 on ClinicalTrials.gov

What this trial studies

This is a phase 1, randomized, placebo-controlled first-in-human study of NNC6989-0001 conducted in adults living with overweight or obesity. The study includes a single ascending dose (Part A) and a multiple ascending dose (Part B) where participants receive either the investigational drug or placebo assigned by chance. Eligible participants are generally healthy adults aged 18–55 with specified BMI ranges and must meet screening safety criteria. The trial is sponsored by Novo Nordisk and conducted at a single early-phase clinical site in Lenexa, Kansas.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–55 who are not of childbearing potential and have a BMI within the study-specified ranges (25.0–34.9 kg/m2 for the single-dose part and up to 39.9 kg/m2 for the multiple-dose part).

Not a fit: People who are pregnant or of childbearing potential, outside the 18–55 age range, have recent significant weight change or dieting, are taking GLP-1 receptor agonists, or have other medical conditions excluded by the investigator are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If successful, the study could identify safe dose ranges and support further testing that might ultimately lead to a new option for weight management.

How similar studies have performed: While other classes of weight-loss drugs such as GLP-1 receptor agonists have shown clinical success, NNC6989-0001 is a novel investigational compound and remains unproven beyond early testing.

Eligibility 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).
* 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.

Where this trial is running

Lenexa, Kansas

• ICON Early Phase Services, LLC — Lenexa, Kansas, United States (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Overweight; Obesity