Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
NCT ID: NCT03308721
Last Updated: 2021-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
99 participants
INTERVENTIONAL
2017-10-16
2020-01-03
Brief Summary
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Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that looks like the study medicine but does not have active ingredients). Which treatment participants get will be decided by chance.
NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use in this study is experimental. Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
The study will last for about 5 months. Participants will have 19 clinic visits with the study doctor. At certain times during the study, participants will have blood draws and 3 different kinds of electrocardiograms. Participants will answer mental health questionnaires. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NNC9204-1177
Dose trial with a sequential trial design
NNC9204-1177 A 1.0 mg/mL
Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
Dose gradually increased to 6000 μg.
Placebo
PLACEBO
Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
Interventions
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NNC9204-1177 A 1.0 mg/mL
Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
Dose gradually increased to 6000 μg.
PLACEBO
Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (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
Exclusion Criteria
* Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk greater than or equal to 5%
* Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), or who intend to donate sperm in the period from screening until 3 months following last administration of the investigational medical product
* Female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and who are not using highly effective contraceptive methods (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or who are pregnant, breast-feeding or intend to become pregnant
18 Years
55 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Overland Park, Kansas, United States
Countries
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References
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Skovgaard D, Haahr PM, Lester R, Clark K, Paglialunga S, Finer N, Friedrichsen MH, Hjerpsted JB, Engelmann MDM. Prevalence of Baseline Cardiac Arrhythmias in Participants with Overweight or Obesity in Phase 1 Clinical Trials: Analysis of 24-Hour Holter Electrocardiogram Recordings. J Clin Pharmacol. 2023 May;63(5):539-543. doi: 10.1002/jcph.2193. Epub 2023 Jan 20.
Other Identifiers
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U1111-1189-1919
Identifier Type: OTHER
Identifier Source: secondary_id
NN9277-4328
Identifier Type: -
Identifier Source: org_study_id