Phase 2
Completed N=706
Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.
Source: ClinicalTrials.gov NCT03856047 ↗Enrolled (actual)
706
Serious AEs
4.1%
Results posted
Jul 2023
Primary outcomePrimary: Change in Body Weight (%) — -6.1; -6.9; -8.5; -9.5 Percentage point of body weight — p=0.0002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight (%) |
-6.1; -6.9; -8.5; -9.5; -10.8; -8.5 | 0.0002 sig |
| SECONDARY Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks |
57.47; 61.98; 75.84; 74.12; 88.74; 76.16 | — |
| SECONDARY Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks |
15.28; 24.06; 35.79; 43.97; 53.49; 39.43 | — |
| SECONDARY Change in Body Weight (Kg) |
-6.6; -7.1; -9.0; -10.1; -11.8; -9.1 | — |
| SECONDARY Change in Waist Circumference |
-6.2; -6.2; -7.7; -8.1; -9.5; -7.4 | — |
| SECONDARY Change in Total Cholesterol |
3.9; -1.8; -3.1; -2.9; -5.4; -9.4 | — |
| SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol |
1.5; 1.9; 1.1; 1.8; 2.6; 0.8 | — |
| SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol |
5.2; -0.3; -0.5; -0.9; -2.7; -5.4 | — |
| SECONDARY Change in Very Low Density Lipoprotein (VLDL) Cholesterol |
-2.8; -3.4; -3.6; -3.8; -5.4; -4.9 | — |
| SECONDARY Change in Triglycerides |
-13.29; -16.25; -17.98; -19.24; -30.35; -25.42 | — |
| SECONDARY Change in Glycosylated Haemoglobin (HbA1c) (%-Point) |
0.0; -0.1; -0.1; -0.1; -0.1; -0.3 | — |
| SECONDARY Change in HbA1c (mmol/Mol) |
-0.5; -0.6; -0.8; -1.0; -1.2; -2.9 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) (mmol/L) |
0.0; 0.0; -0.2; 0.0; -0.2; -0.5 | — |
| SECONDARY Change in FPG (mg/dL) |
-0.7; -0.6; -3.2; 0.0; -3.7; -9.5 | — |
| SECONDARY Change in Fasting Insulin |
103.88; 97.43; 96.44; 90.05; 109.99; 95.80 | — |
| SECONDARY Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) |
-0.05; -0.60; -1.09; -0.72; -2.12; -0.91 | — |
| SECONDARY Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) |
-10.7; -20.0; -18.3; -29.9; -39.7; 16.3 | — |
| SECONDARY Number of Treatment-emergent Adverse Events (TEAEs) |
335; 291; 361; 449; 460; 470 | — |
| SECONDARY Number of Treatment-emergent Serious Adverse Events (TESAEs) |
8; 3; 8; 6; 4; 4 | — |
| SECONDARY Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide |
51; 54; 52; 75; 75 | — |
| SECONDARY Change in Diastolic Blood Pressure (DBP) |
-2.2; 0.8; -1.3; -1.2; -1.8; -2.6 | — |
| SECONDARY Change in Systolic Blood Pressure (SBP) |
-4.9; -0.9; -4.9; -5.0; -6.2; -3.8 | — |
| SECONDARY Change in Pulse |
-2.1; -0.6; -1.2; -2.0; -4.5; 1.6 | — |
| SECONDARY Change in High Sensitivity C-reactive Protein (hsCRP) |
4.5; 4.6; 4.5; 5.8; 5.4; 4.7 | — |
| SECONDARY Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity |
— | — |
| SECONDARY Change in Renin Activity |
2; 0; 1; 1; 1; 0 | — |
| SECONDARY Change in Aldosterone |
0.8; 0.8; 0.7; 2.2; 1.1; 1.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03856047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.