Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 38
- 主要终点
- Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Male or female, age above or equal to 18 years at the time of signing informed consent.
- •BMI 30.0-45.0 kg/m^2 (both inclusive) at the screening visit.
排除标准
- •HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.
- •History of type 1 or type 2 diabetes mellitus.
- •Treatment with glucose-lowering agent(s) within 90 days before screening.
研究组 & 干预措施
Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
干预措施: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg (Drug)
Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)
Participants will receive placebo as an add on to semaglutide 2.4 mg.
干预措施: Semaglutide 2.4 mg and placebo 2.0 mg (Drug)
Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg
干预措施: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg (Drug)
Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)
Participants will receive placebo as an add on to semaglutide 2.4 mg.
干预措施: Semaglutide 2.4 mg and placebo 1.0 mg (Drug)
结局指标
主要结局
Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
时间窗: Part 1: From time of dosing (day 1) to follow-up (week 24)
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
Part 2b: Percentage Change in Body Weight
时间窗: Part 2: Randomisation (week 32), end of treatment (week 48)
Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
次要结局
- Part 2b: Change in Body Weight (kg)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Change in Glycosylated Haemoglobin (HbA1c)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Change in Fasting Plasma Glucose (FPG)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Change in Fasting Insulin(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Change in Waist Circumference(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)(Part 2b: Randomisation (week 32), end of treatment (week 48))
- Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)(From randomisation (week 32) to end of the trial (week 56))
- Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)(From randomisation (week 32) to end of the trial (week 56))