A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese

NCT03600480 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9838-4395U1111-1203-6796
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to find out how NNC0174-0833 taken with semaglutide works in people who are overweight or obese. Both study medicines have been investigated on their own. The study also looks at how the study medicines behave in participant's body and how they are removed from the participant's body. Participants will get 1 of the following 2 treatments - which treatment any participant gets is decided by chance: Semaglutide (a new medicine) and NNC0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine similar to the study medicine but without active ingredients). Participants will get 2 injections per week for 20 weeks. A study nurse at the clinic will inject the medicine with a needle in a skin fold in the participant's stomach area. The study will last for about 16 months, but duration of participation for any participant will last up to about 7.5 months. Participants will have 28 clinic visits with the study staff and some will be overnight visits. Participants will be asked about their health, medical history and habits including mental health questionnaires.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Count of events

  From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176)

Secondary Outcomes (4)

• AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state

  From last dose (Day 134) until end of treatment (Day 141)

• Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state

  From last dose (Day 134) until end of treatment (Day 141)

• AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state

  From last dose (Day 134) until end of treatment (Day 141)

• Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state

  From last dose (Day 134) until end of treatment (Day 141)

Study Arms (2)

NNC0174-0833+Semaglutide

EXPERIMENTAL

Participants will receive increasing doses of NNC0174-0833 along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.

Drug: NNC0174-0833; Drug: Semaglutide

Placebo (NNC0174-0833)+Semaglutide

ACTIVE COMPARATOR

Participants will receive placebo (NNC0174-0833) along with semaglutide. The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks

Drug: Semaglutide; Drug: Placebo (NNC0174-0833)

Interventions

NNC0174-0833 DRUG

Participants will receive increasing dose levels of 0.16 mg, 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg of NNC0174-0833 (subcutaneous \[s.c.\], in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time. Each participant will only be given one dose level.

NNC0174-0833+Semaglutide

Semaglutide DRUG

Participants will receive 2.4 mg of semaglutide (s.c., in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time.

NNC0174-0833+Semaglutide; Placebo (NNC0174-0833)+Semaglutide

Placebo (NNC0174-0833) DRUG

Participants will receive once weekly injections of NNC0174-0833 matched placebo.

Placebo (NNC0174-0833)+Semaglutide

Eligibility Criteria

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

You may qualify if:

• Male or female of non-childbearing potential, aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

You may not qualify if:

• Any disorder at screening which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
• Male subject who is not sexually abstinent or surgically sterilised (vasectomy) and is sexually active with female partner(s) of childbearing potential and is 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), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical product.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Publications (1)

• Enebo LB, Berthelsen KK, Kankam M, Lund MT, Rubino DM, Satylganova A, Lau DCW. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2.4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet. 2021 May 8;397(10286):1736-1748. doi: 10.1016/S0140-6736(21)00845-X. Epub 2021 Apr 22.

  PMID: 33894838 RESULT

MeSH Terms

Conditions

Obesity; Overweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; 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: July 17, 2018
• First Posted: July 26, 2018
• Study Start: July 25, 2018
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)