Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity

NCT03661879 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9423-4393U1111-1208-7677
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study is testing a new medicine for weight control in people with overweight or obesity. The aim of the study is to find out how safe the study medicine is and how it works in the body. Participants will either get NNC9204-1706 (the new study medicine) or placebo (a dummy medicine) - which treatment participants get is decided by chance. NNC9204-1706 is a new medicine which cannot be prescribed by doctors. Participants will get an injection under the skin of participants' stomach each morning for 10 weeks. A medical tool called NovoPen®4 will be used for the injection. Participants must change the part of the pen including the medicine (the cartridge) each day. The study will last for about 16 weeks. Participants will have at least 17 clinic visits and 10 phone calls with the study doctor. At certain times during the study, participants will have blood drawn and 3 different kinds of heart tests (electrocardiograms). Study doctor will ask participants to answer mental health surveys.

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Count of adverse events.

  Days 1-84

Secondary Outcomes (3)

• Change in time-profile (msec) in individual corrected QT interval (ΔQTcI)

  Day 1, Day 84

• AUC0-24h,SS (h*nmol/L); the area under the NNC9204-1706 plasma concentration-time curve from time 0 to 24 hours at steady state

  Days 1-84

• Cmax,SS (nmol/L); the maximum plasma concentration of NNC9204-1706 at steady state

  Days 1-84

Study Arms (2)

NNC9204-1706

EXPERIMENTAL

Participants will receive NNC9204-1706 for 10 weeks. There will be a 2-week follow-up period after the treatment period.

Drug: NNC9204-1706

Placebo (NNC9204-1706)

PLACEBO COMPARATOR

Participants will receive placebo (NNC9204-1706) for 10 weeks. There will be a 2-week follow-up period after the treatment period.

Drug: Placebo (NNC9204-1706)

Interventions

NNC9204-1706 DRUG

Participants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.

NNC9204-1706

Placebo (NNC9204-1706) DRUG

Participants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.

Placebo (NNC9204-1706)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

You may not qualify if:

• Female subject who is of childbearing potential (pre-menopausal and not surgically sterilised) and is sexually active with male partner(s) who are not surgically sterilised (vasectomy) or who is not using highly effective contraceptive methods (Pearl Index less than 1%) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), or are pregnant, breast-feeding or intend to become pregnant.
• Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their nonpregnant female partner(s) (Pearl Index less than 1%), and/or intend to donate sperm in the period from screening until 90 days following administration of the investigational medical product.
• Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Publications (1)

• 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.

  PMID: 36524539 DERIVED

MeSH Terms

Conditions

Nutrition Disorders; Obesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Five (5) cohorts are planned. In each cohort, subjects will be randomised in a 3:1 manner to receive either: 1) NNC9204-1706: 9 subjects or 2) Placebo (NNC9204-1706): 3 subjects

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: September 12, 2018
• Primary Completion: September 5, 2019
• Study Completion: October 9, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)