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

• ClinicalTrials.gov Identifier: NCT03600480
• Recruitment Status: Completed
• First Posted: July 26, 2018
• Last Update Posted: November 17, 2021
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Overweight	Drug: NNC0174-0833; Drug: Semaglutide; Drug: Placebo (NNC0174-0833)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Primary Purpose: Treatment
• Official Title: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Combination With Semaglutide in Subjects Being Overweight or With Obesity
• Actual Study Start Date: July 25, 2018
• Actual Primary Completion Date: June 12, 2020
• Actual Study Completion Date: June 12, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: NNC0174-0833+Semaglutide; 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; 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.; Drug: Semaglutide; 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.
Active Comparator: Placebo (NNC0174-0833)+Semaglutide; 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; 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.; Drug: Placebo (NNC0174-0833); Participants will receive once weekly injections of NNC0174-0833 matched placebo.

Outcome Measures

Primary Outcome Measures :

1. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From first administration of NNC0174-0833 (Day 1) to completion of the post-treatment follow-up (Day 176) ]
   Count of events

Secondary Outcome Measures :

1. AUC0-168h,AM833,SS: the area under the NNC0174-0833 plasma concentration-time curve from 0 to 168 hours at steady state [ Time Frame: From last dose (Day 134) until end of treatment (Day 141) ]
   Measured in nmol*h/L
2. Cmax,AM833,SS: the maximum concentration of NNC0174-0833 in plasma at steady state [ Time Frame: From last dose (Day 134) until end of treatment (Day 141) ]
   Measured in nmol/L
3. AUC0-168h,sema,SS: the area under the semaglutide plasma concentration-time curve from 0 to 168 hours at steady state [ Time Frame: From last dose (Day 134) until end of treatment (Day 141) ]
   Measured in nmol*h/L
4. Cmax,sema,SS: the maximum concentration of semaglutide in plasma at steady state [ Time Frame: From last dose (Day 134) until end of treatment (Day 141) ]
   Measured in nmol/L

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Kansas

Novo Nordisk Investigational Site

Overland Park, Kansas, United States, 66212

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure 1452; Novo Nordisk A/S

More Information

Publications of Results:

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.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03600480
• Other Study ID Numbers: NN9838-4395; U1111-1203-6796 ( Other Identifier: World Health Organization (WHO) )
• First Posted: July 26, 2018
• Last Update Posted: November 17, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: According to the Novo Nordisk disclosure commitment on novonordisktrials.com
• URL: http://novonordisk-trials.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight