Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 706
- Locations
- 53
- Primary Endpoint
- Change in Body Weight (%)
Overview
Brief Summary
This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older at the time of signing the informed consent.
- •Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
- •BMI equal to 30.0 kg/m\^2 or greater or BMI equal to 27.0 kg/m\^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).
Exclusion Criteria
- •HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.
- •A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.
Arms & Interventions
NNC0174-0833, 4.5 mg
Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.
Intervention: NNC0174-0833 (Drug)
NNC0174-0833, 2.4 mg
Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.
Intervention: NNC0174-0833 (Drug)
NNC0174-0833, 1.2 mg
Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.
Intervention: NNC0174-0833 (Drug)
NNC0174-0833, 0.6 mg
Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.
Intervention: NNC0174-0833 (Drug)
NNC0174-0833 0.3 mg
Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.
Intervention: NNC0174-0833 (Drug)
Placebo 2.4 mg (NNC0174-0833)
Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Intervention: Placebo (NNC0174-0833) (Drug)
Placebo 4.5 mg (NNC0174-0833)
Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Intervention: Placebo (NNC0174-0833) (Drug)
Placebo 1.2 mg (NNC0174-0833)
Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Intervention: Placebo (NNC0174-0833) (Drug)
Placebo 0.6 mg (NNC0174-0833)
Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Intervention: Placebo (NNC0174-0833) (Drug)
Placebo 0.3 mg (NNC0174-0833)
Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.
Intervention: Placebo (NNC0174-0833) (Drug)
Liraglutide 3.0 mg
Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.
Intervention: Liraglutide 3.0 mg (Drug)
Placebo 3.0 mg (Liraglutide)
Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.
Intervention: Placebo (Liraglutide 3.0 mg) (Drug)
Outcomes
Primary Outcomes
Change in Body Weight (%)
Time Frame: From baseline (week 0) to week 26
Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days.
Secondary Outcomes
- Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks(Week 26)
- Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks(Week 26)
- Change in Body Weight (Kg)(From baseline (week 0) to week 26)
- Change in Waist Circumference(From baseline (week 0) to week 26)
- Change in Total Cholesterol(From baseline (week 0) to week 26)
- Change in High Density Lipoprotein (HDL) Cholesterol(From baseline (week 0) to week 26)
- Change in Low Density Lipoprotein (LDL) Cholesterol(From baseline (week 0) to week 26)
- Change in HbA1c (mmol/Mol)(From baseline (week 0) to week 26)
- Number of Treatment-emergent Serious Adverse Events (TESAEs)(From week 0 to week 32)
- Change in Aldosterone(From baseline (week 0) to week 26)
- Change in Very Low Density Lipoprotein (VLDL) Cholesterol(From baseline (week 0) to week 26)
- Change in Fasting Plasma Glucose (FPG) (mmol/L)(From baseline (week 0) to week 26)
- Change in Triglycerides(From baseline (week 0) to week 26)
- Change in Glycosylated Haemoglobin (HbA1c) (%-Point)(From baseline (week 0) to week 26)
- Change in FPG (mg/dL)(From baseline (week 0) to week 26)
- Change in Fasting Insulin(From baseline (week 0) to week 26)
- Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(From baseline (week 0) to week 26)
- Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)(From baseline (week 0) to week 26)
- Number of Treatment-emergent Adverse Events (TEAEs)(From week 0 to week 32)
- Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide(From week 0 to week 32)
- Change in Diastolic Blood Pressure (DBP)(From baseline (week 0) to week 26)
- Change in Systolic Blood Pressure (SBP)(From baseline (week 0) to week 26)
- Change in Pulse(From baseline (week 0) to week 26)
- Change in High Sensitivity C-reactive Protein (hsCRP)(From baseline (week 0) to week 26)
- Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity(From baseline (week 0) to week 26)
- Change in Renin Activity(From baseline (week 0) to week 26)