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Liraglutide

Clinical trials in this article study Liraglutide in different groups, including adults with obesity, children with obesity, healthy volunteers, and people with type 2 diabetes. These studies look at how well it works, how safe it is in research settings, and what changes it may cause in weight, hunger, or other health measures.

Table of Contents

Overview of the clinical trials

The provided trial data show research on Liraglutide in several groups, mainly people with obesity and children with obesity, plus healthy volunteers and people with type 2 diabetes.[1][2][3][4] The studies are in Phase 2 and Phase 3, which means they are testing effects in research settings and comparing outcomes in larger groups.[1][2][3][4] The main goals are to measure changes in body weight, BMI, hunger, stomach activity, and blood sugar control.[1][2][3][4]

Trials in adults with obesity

One Phase 2 study, NCT2024-513679-42-00, enrolled 255 adults with obesity or overweight and was completed.[1] It compared multiple dose levels of PF-07976016 against placebo in participants with obesity on a background of liraglutide, and it also included Saxenda as a study treatment listed in the data.[1] The main outcome was the percent change in body weight at Week 16.[1]

This study is important because it focuses on whether adding another study medicine can change weight more than placebo in people already receiving liraglutide-based background treatment.[1] The trial was interventional, which means researchers gave the study treatments and then measured the effects.[1]

Trials in children with obesity

One Phase 3 study, NCT2023-508504-38-00, is authorised and includes 82 children aged 6 to under 12 years with obesity.[3] The study compares Liraglutide 3.0 mg once daily with placebo for weight management in this age group.[3] The main outcome is the relative change in BMI from Week 0 to Week 56.[3]

This trial is focused on a younger population, so it helps answer whether the study treatment can support weight-related care in children with obesity.[3] The use of BMI change as the main outcome shows that the trial is measuring growth-related weight patterns over time, not just short-term change.[3]

Trials in healthy volunteers

Another Phase 3 study, NCT2024-518641-21-00, is authorised and includes 15 healthy volunteers.[2] It studies the effect of liraglutide on MMC activity, gastrointestinal hormones, hunger ratings, and ad libitum food intake.[2] The main outcome is to detect changes in MMC activity after administration of liraglutide compared with placebo.[2]

This type of study does not focus on a disease group alone; instead, it helps researchers observe how the study treatment affects digestive patterns and hunger in people without the target condition.[2] The trial uses saline as the placebo comparison and measures several body responses at once.[2]

Trial in type 2 diabetes

The provided data also include a large Phase 3 study, NCT05433584, in 781 adult participants with type 2 diabetes.[4] In this trial, Liraglutide appears among several treatment options in a study comparing tirzepatide with intensified conventional care.[4] The main outcome is the change from baseline in HbA1c.[4]

This study is not only about one medicine, but it still shows that liraglutide is part of the treatment list being studied in people with type 2 diabetes.[4] HbA1c is a key diabetes measure because it reflects average blood sugar over time.[4]

Main outcomes and what they mean

Across these trials, the main outcomes are practical measures that matter to patients and researchers.[1][2][3][4] The obesity studies look at body weight and BMI, which are common ways to track weight change.[1][3] The healthy volunteer study looks at stomach movement, hunger, and food intake, which helps show how the body responds after treatment.[2] The diabetes study uses HbA1c, which helps show longer-term blood sugar control.[4]

The trial data also show different study sizes, from 15 healthy volunteers to 781 people in the diabetes study.[2][4] This range suggests that the research questions are different: some studies are small and focused on body responses, while others are larger and compare treatment effects in broader patient groups.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2024-513679-42-00 Phase 2 Obesity, Overweight Completed 255
2024-518641-21-00 Phase 3 Obesity Authorised 15
2023-508504-38-00 Phase 3 Obesity Authorised 82
NCT05433584 Phase 3 Type 2 Diabetes Authorised 781

FAQ

  • Who can join clinical trials of Liraglutide? It depends on the study. The trials listed include adults with obesity, children aged 6 to under 12 years with obesity, healthy volunteers, and people with type 2 diabetes.
  • What are the trials of Liraglutide trying to measure? The studies measure outcomes such as body weight, BMI, hunger ratings, food intake, and changes in gastrointestinal activity. One diabetes study measures HbA1c, which is a blood test that shows average blood sugar over time.
  • What phases are the Liraglutide trials in? The trials listed are mainly in Phase 2 and Phase 3. Phase 2 studies usually look at early signs of effect, while Phase 3 studies compare treatment effects in larger groups.
  • Are these trials only for obesity? No. Most of the listed studies focus on obesity, but one trial includes people with type 2 diabetes. Another study looks at healthy volunteers to measure stomach and hormone-related responses.
  • What does a placebo mean in these studies? A placebo is a treatment that does not contain the active study medicine. It is used for comparison so researchers can see whether Liraglutide or another study treatment causes the changes seen in the trial.

Ongoing Clinical Trials on Liraglutide

  • Study of intra-articular liraglutide (4P004) for patients with knee synovitis and osteoarthritis

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Poland Spain

  • Study on the Effects of Liraglutide on Hunger and Digestion in Obese Patients

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Evaluation of Long-Term Efficacy and Safety of Tirzepatide Versus Intensified Conventional Care in Early Treatment of Type 2 Diabetes in Adults

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Italy Romania Slovakia

  • Study on the Effects of PF-07976016 and Liraglutide in Adults with Obesity

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Hungary Poland

  • Study on Liraglutide for Weight Management in Children Aged 6 to 12 with Obesity

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Portugal

Glossary

  • Obesity: A condition where a person has too much body fat, which can affect health.
  • Overweight: A body weight that is higher than what is usually considered healthy for a person’s height.
  • Healthy volunteers: People who do not have the study disease and take part in research so scientists can measure how the study treatment affects the body.
  • Phase 2: A trial stage that looks at early evidence of benefit and continues to study safety and how the treatment works in a smaller group.
  • Phase 3: A later trial stage that compares treatments in larger groups and helps confirm how well a treatment works.
  • Placebo: An inactive treatment used for comparison in a study.
  • BMI: Body mass index, a number based on height and weight that helps doctors estimate if a person has a healthy body weight.
  • HbA1c: A blood test that shows the average blood sugar level over about 2 to 3 months.
  • Gastrointestinal hormones: Hormones made in the stomach and intestines that help control digestion, hunger, and fullness.
  • Migrating motor complex (MMC): A pattern of muscle movement in the stomach and intestines that helps move food and fluid through the digestive system.
  • WOMAC Pain subscore: A score used in joint pain studies to measure pain in osteoarthritis.
  • Ad libitum food intake: How much food a person eats when they are allowed to eat as much as they want.

References

  1. https://clinicaltrials.gov/study/2024-513679-42-00
  2. https://clinicaltrials.gov/study/2024-518641-21-00
  3. https://clinicaltrials.gov/study/2023-508504-38-00
  4. https://clinicaltrials.eu/trial/evaluation-of-long-term-efficacy-and-safety-of-tirzepatide-versus-intensified-conventional-care-in-early-treatment-of-type-2-diabetes-in-adults/