A Research Study Looking at a New Study Medicine (NNC0194-0499) for Weight Control in People With Overweight or Obesity

NCT03479892 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9499-4287U1111-1193-7228
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 visits to the clinic.

Conditions

Metabolism and Nutrition Disorder; Obesity

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  count of events

  From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112)

Secondary Outcomes (15)

• Change in heart rate

  Baseline (Day 1), Follow-up (Day 112)

• Change in biochemistry

  Baseline (Day -1), Follow-up (Day 112)

• Change in haematology

  Baseline (Day -1), Follow-up (Day 112)

• Change in fibrinogen

  Baseline (Day -1), Follow-up (Day 112)

• Change in prothrombin time read as international normalised ratio (INR)

  Baseline (Day -1), Follow-up (Day 112)

Study Arms (2)

NNC0194-0499

EXPERIMENTAL

Participants will receive increasing doses of NNC0194-0499. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.

Drug: NNC0194-0499

Placebo

PLACEBO COMPARATOR

Participants will receive NNC0194-0499 matched placebo. The treatment period from first treatment (Day 1) to end of the treatment (Day 85) will be 12 weeks.

Drug: Placebo

Interventions

NNC0194-0499 DRUG

Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level. Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.

NNC0194-0499

Placebo DRUG

Participants will receive once weekly injections of NNC0194-0499 matched placebo.

Placebo

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent
• Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported)
• Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s)
• Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
• Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit

You may not qualify if:

• Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
• Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening
• History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

San Antonio, Texas, 78209, United States

Location

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

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 27, 2018
• Study Start: March 13, 2018
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)