Clinical trial NCT04010786: A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity
Official title: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of NNC0247-0829 in Adults With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-07-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First human dose trial; a single-centre, placebo-controlled, double-blind (within cohorts), randomised SD and MD ascending dose trial with a sequential trial design
Primary purpose: TREATMENT

Brief summary: This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.


Eligibility criteria: Inclusion Criteria:

* Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive) in the SD cohorts and between 27.0 and 39.9 kg/m\^2 (both inclusive) in the MD cohorts at screening. Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

* Male subject who is not surgically sterilised (vasectomised) and is sexually active with female partner of childbearing potential in the absence of highly effective contraception.
* Any disorder, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
* Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Mild painkillers are permitted until 24h prior to screening.

Primary outcomes:
measure: For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of first dosing (Day 1) until Day 71
measure: For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of first dosing (Day 1) until Day 85
Secondary outcomes:
measure: For SD cohorts: Number of injection site reactions
timeFrame: From time of first dosing (Day 1) until Day 71
measure: For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies
timeFrame: From time of first dosing (Day 1) until Day 71
measure: For MD cohorts: Number of injection site reactions
timeFrame: From time of first dosing (Day 1) until Day 85
measure: For MD cohorts: Occurrence of anti-NNC0247-0829 antibodies
timeFrame: From time of first dosing (Day 1) until Day 85
measure: For (SD) cohorts: The area under the NNC0247-0829 serum concentration-time curve from time 0 to infinity
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (from Day 71 up to Day 134, depending on the dose cohort)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services, LLC
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: