Overweight

125

Review clinical trials related to Overweight. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health

The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.

Participants needed: 94
Trial details
Phase: Early Phase 1Age: 30-79Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jul 13, 2026
Eligibility criteria

Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30... [+3]

Have diagnosis of CVD, [+7]

Status: Recruiting

Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change

Background: In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home. Objective: To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks. Eligibility: Adults aged 19 to 50 years with a body mass index of 25 or more. Design: Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples. Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants' homes. They will eat only the foods delivered. Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....

Participants needed: 42
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Updated: Jul 13, 2026Locations: 1
Eligibility criteria

Stated willingness to comply with all study procedures and availability for the... [+4]

Subjects with cardiac pacemakers or other implants that may be affected by or af... [+16]

Status: Recruiting

AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Participants needed: 300
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Jul 13, 2026Locations: 80
Eligibility criteria

Male or female (sex at birth) [+2]

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central lab... [+4]

Status: Recruiting

AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Participants needed: 300
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Jul 13, 2026Locations: 92
Eligibility criteria

Male or female (sex at birth) [+2]

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central lab... [+4]

Status: Recruiting

Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity

The primary objective of the trial is to evaluate the effect of maridebart cafraglutide on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in postmenopausal female participants living with overweight or obesity.

Participants needed: 45
Trial details
Phase: Phase 1Age: 45-65Biological sex: FemaleType: InterventionalSponsor: AmgenUpdated: Jul 1, 2026Locations: 3
Eligibility criteria

Participants must be postmenopausal females 45 to 65 years of age. Postmenopausa... [+4]

History or evidence of any clinically significant medical condition, abnormal ph... [+22]

Status: Not yet recruiting

Impact of Overweight, Obesity, and Lifestyle Changes on Work Performance and Well-Being in Medical Residents

The goal of this observational study is to evaluate the impact of overweight, obesity, and lifestyle changes on work performance, work ability, quality of life, and overall well-being in medical residents working in hospital and university settings. The main questions it aims to answer are: * Is overweight and obesity associated with reduced work productivity, including absenteeism, presenteeism, and perceived work ability? * Is overweight and obesity associated with lower health-related quality of life, psychological well-being, and worker well-being? * Do lifestyle improvements and clinically significant weight loss over a 12-month period lead to measurable improvements in work productivity, work ability, quality of life, and well-being? * Do changes in physical health, mental health, and organizational factors mediate the relationship between weight loss and occupational outcomes? Participants will undergo assessments at baseline and after 12 months of follow-up. Researchers will evaluate associations between body weight status, health outcomes, and occupational performance over time. Participants will: Attend occupational health surveillance visits at baseline and at 12 months. Undergo anthropometric measurements, including body mass index (BMI), waist circumference, and blood pressure assessment. Provide blood samples for routine laboratory evaluation, including metabolic, cardiovascular, inflammatory, and hematological parameters. Complete validated questionnaires assessing health-related quality of life (SF-12), work ability (Work Ability Index), work productivity and activity impairment (WPAI), fatigue (Fatigue Severity Scale), psychological well-being (PGWBI), mental health (DASS-21), worker well-being (NIOSH WellBQ), and resilience (CD-RISC). Provide information on sociodemographic characteristics, lifestyle habits, medical history, occupational characteristics, and work-related exposures. The study will estimate the prevalence of overweight and obesity in a cohort of medical residents and investigate their association with occupational and health-related outcomes. Longitudinal analyses will examine whether changes in lifestyle behaviors and body weight are associated with changes in productivity, absenteeism, presenteeism, work ability, quality of life, and well-being over a 12-month observation period. The study will also explore potential mechanisms linking weight status and occupational outcomes, including physical health, psychological health, and organizational factors.

Participants needed: 600
Trial details
Biological sex: AllType: ObservationalSponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Male and female medical residents (physicians in specialty training). [+3]

Pregnancy at baseline or occurring during the follow-up period. [+3]

Status: Recruiting

AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Participants needed: 300
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Jun 26, 2026Locations: 80
Eligibility criteria

Male or female (sex at birth) [+2]

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central lab... [+4]

Status: Recruiting

AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Participants needed: 300
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Jun 29, 2026Locations: 92
Eligibility criteria

Male or female (sex at birth) [+2]

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central lab... [+4]

Status: Not yet recruiting

A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight

This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.

Participants needed: 300
Trial details
Phase: Phase 2Age: 18-74Biological sex: AllType: InterventionalSponsor: Boehringer IngelheimUpdated: Jun 24, 2026Locations: 57
Eligibility criteria

Male or female, age ≥18 to <75 years at the time of signing informed consent, an... [+5]

Body weight increase or decrease (self-reported) of greater than 5% in the 3 mon... [+7]

Status: Recruiting

A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity

This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.

Participants needed: 234
Trial details
Phase: Phase 1Age: 18-64Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

Aged 18-64 years (both inclusive) at the time of signing informed consent [+2]

Previous participation in study(s) with an amylin analogue. Participation is def... [+1]

Status: Recruiting

HealthyTogether: RCT of a Dyadic Weight Management Intervention

Four in five Veterans have overweight or obesity. However, few eligible Veterans achieve meaningful weight loss in VA's national MOVE! Weight Management Program. Family and friends strongly influence a person's health behaviors and weight. Including a close family member or friend in weight management may improve weight management outcomes. This study will test whether an 14-week, 8-session virtual weight management program that includes Veterans and a support person (e.g., family member or friend) leads to weight loss. The investigators will also test whether the program leads to improvements in weight-related health behaviors, including physical activity and diet, and relationship quality.

Participants needed: 320
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Jun 26, 2026Locations: 2
Eligibility criteria

Age 18 or higher. [+9]

not fluent in English [+21]

Status: Recruiting

Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)

Background: Artificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes. Objective: To see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized. Eligibility: People ages 18-60 who: * Are black or Hispanic * Weigh more than 110 pounds * Have a body mass index of 25-40 * Do not have a condition that requires drug treatment Design: Participants will be screened with: * Medical history * Physical exam * Blood, heart, and urine tests Participants must not eat or drink anything with artificial sweeteners throughout the study. Over 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study. Overnight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes: * An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours. * A piece of fat tissue may be taken from the abdomen (biopsy). * Participants will have a sweet drink. Blood samples will be taken over 2 hours. Then participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries. Overnight Visit 2 repeats Visit 1 except the biopsy. Then participants will take the capsules for another 2 weeks. Overnight Visit 3 repeats Visit 1. Participants may be contacted by phone within 4 weeks after they finish.

Participants needed: 150
Trial details
Phase: Phase 2Age: 18-60Biological sex: FemaleType: InterventionalSponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)Updated: Jun 24, 2026Locations: 1
Eligibility criteria

Age: between 18 and 60 years [+6]

Current use of prescription or non-prescription medication(s), herbal medication... [+12]

Status: Not yet recruiting

Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health

The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.

Participants needed: 94
Trial details
Phase: Early Phase 1Age: 30-79Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jun 25, 2026
Eligibility criteria

Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30... [+3]

Have diagnosis of CVD, [+7]

Status: Recruiting

A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

Participants needed: 300
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hoffmann-La RocheUpdated: Jun 26, 2026Locations: 3
Eligibility criteria

Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m²) for participants... [+2]

History of Type 1 diabetes mellitus (T1DM) [+9]

Status: Recruiting

Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events

The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.

Participants needed: 114
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Jun 25, 2026Locations: 11
Eligibility criteria

Male or female (sex at birth) [+4]

Female who is pregnant, breast-feeding, or intends to become pregnant or is of c... [+5]

Status: Not yet recruiting

A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide

The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.

Participants needed: 650
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Jun 25, 2026Locations: 46
Eligibility criteria

Male or female (sex at birth). [+1]

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole [mmol/mol]) as measu... [+2]

Status: Not yet recruiting

A Study of Eloralintide (LY3841136) in Participants With Overweight or Obesity

The main purpose of the study is to measure and compare the effects of eloralintide and placebo on insulin sensitivity (how your body responds to insulin), metabolic health (things like sugar and cholesterol), and body weight in participants with obesity or overweight. For each participant, the study will last about 35 weeks and include 3 in patient visits totaling 7 days.

Participants needed: 115
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 24, 2026Locations: 1
Eligibility criteria

Have an hemoglobin A1c (HbA1c) value at screening of less than 6.5 percent (%). [+3]

Have type 1 or type 2 diabetes mellitus, a history of ketoacidosis, or of hypero... [+8]

Status: Not yet recruiting

AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight

The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Participants needed: 400
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Jun 25, 2026Locations: 11
Eligibility criteria

Male or female (sex assigned at birth, inclusive of all gender identities). [+1]

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central lab... [+2]

Status: Recruiting

A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.

Participants needed: 400
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 24, 2026Locations: 40
Eligibility criteria

See Master Protocol CWMM (NCT06143956) for inclusion criteria

Have type 1 diabetes or type 2 diabetes [+4]

Status: Recruiting

A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.

Participants needed: 900
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 23, 2026Locations: 183
Eligibility criteria

Are on stable incretin therapy at screening [+7]

Have a prior or planned surgical treatment for obesity (liposuction, cryolipolys... [+11]

Status: Recruiting

A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight

The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study. Participants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.

Participants needed: 800
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 23, 2026Locations: 129
Eligibility criteria

Confirmed history of moderate-to-severe OSA [+6]

Have a prior or planned surgical treatment for obesity (liposuction, cryolipolys... [+10]

Status: Recruiting

A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

Participants needed: 1,980
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 23, 2026Locations: 169
Eligibility criteria

30 kilogram per square meter (kg/m2) OR [+6]

Have a prior or planned surgical treatment for obesity (liposuction, cryolipolys... [+9]

Status: Recruiting

A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.

Participants needed: 1,035
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 23, 2026Locations: 159
Eligibility criteria

Have type 2 diabetes [+3]

Have a prior or planned surgical treatment for obesity (liposuction, cryolipolys... [+13]

Status: Recruiting

A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes

The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.

Participants needed: 200
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 23, 2026Locations: 42
Eligibility criteria

Have type 2 diabetes [+7]

Have any form of diabetes other than type 2 diabetes [+17]

Status: Recruiting

Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients

This is a randomized, double-blind, placebo-controlled, dose-finding, Phase 2a study designed to evaluate the safety and efficacy of KDS2010 in overweight or obese patients. Based on preliminary efficacy observed in the Phase 1 study, this clinical trial is being conducted in Korea. After a minimum 2-week run-in period, subjects who meet the inclusion and exclusion criteria will be randomized to the treatment group or placebo group at a 2:1 ratio in each stage. Subjects will receive the investigational product for 12 weeks following randomization. The study will be conducted in three stages. Approximately 75 subjects will be enrolled, with 6 subjects in the KDS2010 120 mg group and 3 subjects in the placebo group in Stage 1, 22 subjects in the KDS2010 180 mg group and 11 subjects in the placebo group in Stage 2, and 22 subjects in the KDS2010 240 mg group and 11 subjects in the placebo group in Stage 3. The primary objectives are to assess the efficacy and safety of KDS2010 in overweight or obese patients. Exploratory objectives include evaluating the proportion of subjects achieving a weight reduction of more than 25% from baseline at Week 12 and assessing changes in MAO-B specific activity and adiponectin levels. Based on nonclinical and Phase 1 clinical data, KDS2010 will be administered orally once daily at doses of 120 mg, 180 mg, and 240 mg throughout the study.

Participants needed: 75
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: NeuroBiogen Co., LtdUpdated: Jun 24, 2026Locations: 3
Eligibility criteria

Adult males and females aged 18 years or older (or the legal age of adulthood in... [+7]

Subjects with a weight change of 5% or more within 12 weeks before screening [+38]