2026-526797-16-00RecruitingPhase 2
A study assessing the safety, tolerability, pharmacokinetics and efficacy of single and multiple doses of NNC0638-0355 in participants with overweight or obesity
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- 1. Relative change in body weight from baseline (week 0) to (week 26)
Study Overview
Brief Summary
To compare the effect of multiple doses of NNC0638-0355 versus placebo on relative change in body weight from baseline (week 0) to week 26 in participants with overweight or obesity.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-64 in Part F (both inclusive) at the time of signing the informed consent.
- •BMI between 27.0 and 39.9 kg/m2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Considered to be generally healthy 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
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Any condition, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
- •HbA1c ≥ 6.5% (48 mmol/mol) at screening.
- •Clinically significant abnormalities, as judged by the investigator, in vitamin D, PTH and total calcium, as determined by central laboratory at screening
Outcomes
Primary Outcomes
1. Relative change in body weight from baseline (week 0) to (week 26)
1. Relative change in body weight from baseline (week 0) to (week 26)
Secondary Outcomes
- 1. Change in body weight from baseline (week 0) to (week 26)
- 2. AUCSS; area under the NNC0638-0355 plasma concentration-time curve at steady state from first NC0638-0355 administation to 32 weeks.
- 3. CmaxSS; maximum observed NNC0638-0355 plasma concentration from first NC0638-0355 administation to 32 weeks.
Investigators
Novo Nordisk A/S
Scientific
Novo Nordisk A/S
Study Sites (1)
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