Clinical Research Directory

Safety and Analgesic Efficacy of the Biased μ-Opioid Receptor Agonist Tegileridine for Post-Operative Analgesia in Patients Undergoing Bariatric Surgery

This single-center, stratified randomized double-blind trial tests tegileridine, a new pain drug, for pain relief after weight-loss surgery. Researchers will compare tegileridine with standard opioid pain medicine. Eligible patients having bariatric surgery will be randomly assigned to one of the two treatment groups. Patients and study teams will not know which treatment each participant receives. Participants will be grouped based on whether they have obstructive sleep apnea (OSA). The primary measurement is postoperative recovery quality in the first 24 hours after surgery using the QoR-15 survey. The study will also track pain scores, rescue pain medication use, and drug side effects for 7 days after surgery. There is no guaranteed benefit for participants. Study pain medicines may cause side effects. Doctors will provide rescue treatment for uncontrolled pain.

Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss

A study of ALV-100 to assess efficacy, safety and tolerability among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with incretin-based therapies.

Study of UBT37034 Injection

This is a study of UBT37034 for injection in participants who have obesity or are overweight. The main purpose is to learn more about the safety, tolerability, drug concentration, drug action and immune response of repeated UBT37034 administration. This is a single-center, randomized, double-blind, placebo-controlled study with multiple ascending doses. A total of 40 participants will be enrolled in 4 different dose groups. Participants will receive UBT37034 or placebo in an 8:2 random ratio with dose titration. The study will last up to 24 weeks and includes screening, treatment and safety follow-up periods.

Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 for Overweight and Obesity

This study is designed as a preliminary investigation to evaluate the weight-loss efficacy and safety of AKM Lab-01 in an overweight or obese population. It is an interventional, radomized, double-blind, placebo-controlled clinical trial. Participants who meet the eligibility criteria will be randomly assigned to receive AKM Lab-01 or a matching placebo. The intervention will be administered once daily for 3 months. Baseline metrics, along with blood, urine, and stool samples, will be collected from participants, before and after the AKM Lab-01 intervention. The analysis will focus on changes in body weight, blood lipids, blood glucose, and gut metagenomic profiles (from stool samples). Furthermore, metabolomic analysis of blood and stool samples will be conducted to explore the potential machanisms through which AMK Lab-01 influences body weight.

A Trial to Examine the Effects of a Weight Loss Program Emphasizing Protein, Dietary Fiber, and Exercise (30-30-30 Plan)

The purpose of this study is to learn whether following an online weight loss program with specific dietary and exercise goals (the 30-30-30 plan) can help improve weight loss and other markers of health when compared to an online weight loss program on its own.

Long-term Follow-up After Childhood Obesity

The goal of this observational study is to learn about the long-term effects on health and well-being of treatment for overweight in childhood or adolescence using the Children's Obesity Clinic Treatment protocol (the Holbæk Model) (HM). The study has two parts: * An active follow-up study, where participants are invited to take part in new measurements and questionnaires * A register-based study, which uses existing data on diagnoses, medication use, and school well-being The submitted protocol primarily focuses on the active follow-up study. The register-based study covers diagnoses, medication use, and school-related well-being and is described in the section "Detailed description". In the active follow-up study, researchers will examine: * Body measurements such as height, weight, and waist circumference * Body composition * Psychosocial well-being and mental health * Eating behaviors in young adults Participants will be followed for up to 20 years after treatment initiation. Where possible, results will be compared with a group of people of the same age from the same area who did not receive this treatment. This will help show whether their development differs from that of the general population. The aim is to use the findings to improve future follow-up care and support for people who were treated for overweight as children. The study includes two groups: 1. A treatment group of individuals treated at the Holbæk Pediatric Department between 2008 and 2025 2. A comparison group from the general population, recruited between 2010 and 2016 The study will take place in two phases: * A pilot phase (about 1.5 years) to test procedures and recruitment * A main phase (about 3 years) Participants are invited to one follow-up visit. During this visit: * Body measurements will be taken * Body composition will be assessed * Participants will complete questionnaires The study team will ensure that all participants are treated respectfully and without stigma. Flexible options, including home visits, are offered to make participation easier.

TRPTI Metabolic and GLP-1 Pharmacodynamic Study

The goal of this clinical trial is to assess whether TRPTI™ supplementation affects GLP-1 and related metabolic markers in generally healthy adults who are overweight or obese (BMI 25.0-34.9 kg/m², aged 30 years and older). Researchers will compare TRPTI™ 150 mg to a matching placebo capsule to see if TRPTI™ produces a meaningful difference in GLP-1 response and associated metabolic and appetite-related markers over 8 hours. Participants will attend two 9-hour clinic visits (crossover design, with a minimum 6-day washout between visits).

Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits

This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health. Whether long-term fasting and dietary fibre interventions could be combined to achieve synergistic improvements in host metabolic health is however unknown. The goal is to provide a proof of concept in a human trial that supplementing 10±4 days fasting with dietary fibre synergistically improves metabolic outcomes via gut microbiome-mediated effects. To assess this, we aim to analyse gut microbiome changes, functional outputs, and key metabolic markers such as butyrate production, glycaemic control and ketosis. The randomised controlled trial includes 75 participants and has two arms: one involving fasting with fibre supplementation (n = 50) and one involving fasting without fibre supplementation (n = 25). All participants will undergo a fasting period of 10±4 days according to the Buchinger Wilhelmi protocol, followed by a stepwise reintroduction of food of up to 4 days. As dietary fibre we will use maize-derived resistant starch type IV, selected based on its ability to stimulate beneficial gut microbes like Oscillibacter and corn starch as placebo. Two main visits will be conducted: before and at the end of the fasting period. During these visits, blood and stool samples will be collected, and questionnaires will be completed. Additionally, daily measurements of anthropometric parameters and well-being will be recorded. Stool samples will also be collected one month afterwards as a follow-up. Participants' metabolic health will be evaluated through various clinical parameters (e.g., body measurements, blood pressure, glycaemic control, ketones, well-being). Additionally, multi-omics data, including metagenomics and metabolomics, will provide insight into the composition of the microbiome, as well as its outputs and functions. Furthermore, the effects of fasting on extracellular vesicles in blood will be explored.

Two-Week Stair-Climbing Exercise Snacks and Metabolic Health in Adults With Overweight or Obesity: A Pilot Study

This pilot study will evaluate whether brief bouts of stair climbing performed throughout the day for two weeks can improve metabolic health, cardiovascular fitness, and other health-related outcomes in adults with overweight or obesity who do not regularly exercise. Participants will complete approximately 6-8 brief stair-climbing "exercise snacks" per day for 14 days, with each bout consisting of approximately 60 total stair steps performed at a challenging but safe self-selected pace. Participants will complete baseline and post-intervention assessments at Saint Louis University. These assessments will include continuous glucose monitoring and standardized meal testing to evaluate glucose responses, as well as measures of aerobic fitness, anaerobic power, body composition, waist circumference, and muscular strength. The study will also evaluate adherence, perceived exercise intensity, and the feasibility of incorporating brief stair-climbing bouts into daily life.

Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women

The menopausal transition is associated with significant hormonal changes that negatively impact many women's quality of life. Vasomotor symptoms, sleep disturbances, mood changes, and genitourinary symptoms are frequently reported during this period. Concurrently, there is a tendency toward increased body weight and fat redistribution, specifically central fat accumulation, which raises the risk of metabolic diseases. Although hormonal therapy is effective, it is not suitable for all women, necessitating the consideration of non-pharmacological strategies as therapeutic alternatives. Scientific evidence indicates that healthy dietary patterns and weight loss are associated with reduced menopausal symptom severity. The objective of the research is to evaluate the effects of a dietary intervention based on the guidelines of the Dietary Guidelines for the Brazilian Population (GAPB) on the reduction of menopausal symptoms. A randomized clinical trial will be conducted to assess whether improving dietary quality and reducing body weight contribute to alleviating menopausal symptoms. Participants will be assigned to two groups: a control group (CG) and an intervention group (IG). Both groups will receive nutritional guidance based on the GAPB; however, the CG will receive the guidelines in printed format, whereas the IG will receive them through group sessions. The study will include perimenopausal or postmenopausal women who are overweight or obese and experiencing menopausal symptoms. Validated instruments will be administered at the beginning and end of the study to assess dietary patterns, menopausal symptoms, and nutritional status.

Standardized Large Yellow Tea Extract for Glucose and Lipid Metabolism in Overweight Adults With Hypertriglyceridemia

This multicenter, prospective, randomized, blinded, parallel-group controlled trial will evaluate the effects of standardized large yellow tea extract on glucose and lipid metabolism in overweight adults with elevated triglyceride levels. Approximately 138 participants aged 18 to 60 years will be enrolled at three study centers in China and randomly assigned in a 1:2 ratio to a placebo control group or a standardized large yellow tea extract group. Participants will receive the assigned intervention for 12 weeks, together with standardized lifestyle guidance. The primary objective is to compare the change in fasting triglyceride levels from baseline to week 12 between the two groups. Secondary objectives include evaluating changes in other lipid parameters, glucose metabolism, body weight, body mass index, waist circumference, blood pressure, and safety and tolerability. Exploratory analyses will assess plasma and/or urine metabolomic profiles and potential biomarkers related to response to the tea intervention. Participants will also be followed through week 24 for longer-term safety assessment and changes in glucose and lipid metabolism.

Retrospective Continuous Glucose Monitor (CGM) Study on Glycemic Response and Body Composition in College Students

This retrospective study evaluates the real-world effect of individualized glycemic response-guided dietary management, based on continuous glucose monitoring (CGM), on weight and body composition in overweight and obese university students. All data for this analysis were retrospectively retrieved from the archived records of a randomized controlled trial conducted at He University, in which 60 students (body mass index \[BMI\] ≥ 24 kg/m² or elevated body fat percentage) had worn CGM sensors for 4 weeks. The archived records show that the exposed group (n = 30) had received individualized dietary guidance generated from their own glucose responses, including structured CGM reports, meal composition and eating-order advice, and standardized feedback, whereas the non-exposed group (n = 30) had worn CGM without receiving any dietary guidance. One non-exposed participant was excluded from this retrospective analysis for missing primary outcome data, leaving 59 participants for analysis. The archived dataset contains body composition (weight, body mass index \[BMI\], body fat mass, percent body fat, skeletal muscle mass, visceral fat level) and eating behavior records at Day 0, Day 28, and Day 90. This analysis examines whether the 4-week intervention produced sustained, fat-mass-driven improvements in body composition and whether changes in eating behavior mediated these effects.

Exercise, Chronotype, and Prediabetes

The goal of this clinical trial is to find out whether exercising at the right time of day, based on a person's natural body clock, leads to greater health benefits in people living with prediabetes. The main question it aims to answer is whether doing a single session of exercise in the morning or in the evening affects how the body handles sugar differently in adults with prediabetes who have an extreme natural body clock. This will be done by comparing three conditions (no-exercise, morning exercise, and evening exercise) within the same participant. Each condition will be tested on a different day, with at least 14 days between the test days. During the no-exercise test days, participants will come to the study centre and will only be allowed to do sedentary activities (e.g. office work, reading, or screen time). During the morning exercise test days, participants will perform an exercise session at 9:00 am that involves short periods of very hard effort followed by short rest periods. Whereas for the evening exercise test days, the same type of exercise will be performed at 5:00 pm.

Community Physical Exercise Program in Chronic Disease

This study focuses on promoting physical activity (PA) through the implementation of a Community Physical Exercise Program for Chronic Diseases (CPEP-CD), targeting individuals aged 50 years and older with at least two of the following conditions: cardiovascular and/or cerebrovascular disease or risk (CVD), overweight, diabetes mellitus (DM), and musculoskeletal diseases. The primary objective is to improve muscle and cardiorespiratory health and well-being, while also contributing to a more objective and evidence-based exercise prescription for these pathological conditions. Population ageing is a global challenge associated with an increased prevalence of chronic diseases that compromise quality of life (QoL). A sedentary lifestyle is linked to declines in muscle function and cardiorespiratory fitness and is considered a major risk factor for morbidity and mortality. Consequently, physical exercise is widely recommended as a key non-pharmacological intervention across multiple chronic diseases. According to World Health Organization (WHO) guidelines, regular PA is a protective factor in the prevention and management of non-communicable diseases, including cardiovascular and cerebrovascular diseases and DM. In addition, PA provides mental health benefits, supports healthy weight maintenance, and enhances overall well-being. In adults, regular PA is associated with reductions in all-cause mortality, cardiovascular mortality, and the incidence of hypertension. Within this context, the aim of this project is to implement a community-based physical exercise program for individuals with chronic disease and multimorbidity, focusing on CVD and cerebrovascular disease or risk, DM, and OA. The program integrates existing exercise prescription guidelines while personalizing exercise progression according to both disease-specific and multimorbidity profiles. The primary outcomes include improvements in cardiorespiratory fitness, muscular strength, bone health, functional capacity, and QoL. Additionally, through individualized training monitoring, this study seeks to establish an exercise prescription tailored to the most prevalent combinations of chronic diseases, thereby providing more objective and practical guidance for family physicians, exercise professionals, and rehabilitation specialists, and supporting more personalized and targeted exercise-based strategies for chronic disease prevention and management.

Lifestyle Changes, Mushroom Supplementation, and Bupropion to Reduce Adiposity and Cardiometabolic Risk

The increasing prevalence of obesity, its serious health consequences, and the substantial economic burden on healthcare systems underscore a pressing need for effective, long-term prevention strategies that can be implemented in primary care. Emerging evidence suggests that combining lifestyle modification with dietary supplements and pharmacological treatment may enhance and prolong intervention effects, yet comparative long-term data on their individual and combined efficacy are limited. Therefore, this study aims to evaluate the independent and additional effects of a comprehensive lifestyle intervention, a mushroom-based dietary supplement, and bupropion treatment over 12 months, to identify more effective and sustainable strategies for obesity prevention in overweight and obese adults.

Phase 1 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity

This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation phase I clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105 injection in Chinese non-diabetic overweight or obese participants. The study plans to enroll 36 male and female participants. Three dose groups were preset, with 12 participants in each. They were randomly assigned to receive MWN105 injection or placebo at a ratio of 5:1 and were administered the treatment in a titration manner, once a week, with a dose increase every two weeks until reaching the target dose. The administration lasted for 8 weeks. The study consists of a 2-week screening period, an 8-week administration/observation period, and a 4-week follow-up period, totaling 14 weeks. The primary endpoint is the incidence of adverse events. Secondary endpoints include pharmacokinetics, pharmacodynamics, and immunogenicity.

Phase 2 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetic characteristics, efficacy, and safety of MWN105 Injection in non-diabetic participants with overweight or obesity. Approximately 120 participants will be randomized to receive different dose levels of MWN105 Injection or matching placebo, administered subcutaneously once weekly for a total treatment duration of 24 weeks, with dose titration from 15 mg to the target dose. The primary endpoint is the percent change from baseline in body weight at Week 24. Secondary endpoints include changes in body weight and metabolic parameters, bone mineral density, pharmacokinetic parameters, immunogenicity, and safety.

Phase 2 Study of MWN109 Tablet for Weight-Loss Maintenance in Participants With Overweight or Obesity

This study adopted a randomized, open-label design, aiming to preliminarily explore the weight-loss maintenance effect of MWN109 tablets when administered continuously for 24 weeks in non-diabetic overweight or obese participants. Participants who met the inclusion criteria were randomly assigned (1:1) to either the QD or QW administration group of MWN109 tablets, with the dose grouping in the MWN109-II-WL study serving as a random stratification factor. This study included a maximum screening period of 2 weeks, a 24-week treatment observation period, and a 2-week safety follow-up period, totaling 28 weeks. The primary endpoint was the percentage change in weight from baseline after 24 weeks of administration. The secondary endpoints included the change in weight from baseline after 24 weeks of administration, as well as the change in waist circumference from baseline.

A Study to Evaluate Different Administration Conditions and the Food Effect of MWN109 Tablets in Chinese Participants

This is a randomized, open-label, multiple-dose study to evaluate the effects of different volumes of administration water, post-dose fasting duration, and high-fat diet on the pharmacokinetics of the 15 mg dose of MWN109 tablets in adult Chinese participants, as well as to assess its safety, tolerability, and immunogenicity. The study consists of two parts. Part 1 is an administration condition study, which includes 6 groups stratified by post-dose fasting duration and administration water volume. Part 2 is a food-effect study, comprising 3 groups stratified by dietary conditions.. A total of 162 participants are planned to be enrolled. The primary endpoint is pharmacokinetics (PK). PK parameters include Cmax, Cmin, AUC0-t, AUC0-∞, Tmax, and t1/2. Secondary endpoints include safety (adverse events \[AEs\] and serious adverse events \[SAEs\]) and immunogenicity (anti-drug antibodies \[ADAs\]).

Phase 1 Clinical Study of MWN105 Injection in Healthy Chinese Volunteers

This study is a randomized, double-blind, placebo-controlled, single-dose and multiple-dose, dose-escalation phase I clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of MWN105 injection in healthy Chinese volunteers, and to provide a reference for the next clinical trial. This study includes a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. The SAD study consists of 4 dose groups; the MAD study consists of 2 dose groups and adopts a 4-week dose titration scheme. The study plans to enroll 55 volunteers. The primary endpoint is the incidence of adverse events. The secondary endpoints are the pharmacokinetic and pharmacodynamic characteristics and immunogenicity endpoints.

BfedBwell INSPIRE Pilot

This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, exercise, sleep health, and stress management. The intervention integrates the BfedBwell survivorship nutrition program with the BfitBwell clinical exercise oncology program. The augmented BfedBwell program includes: (1) a core education curriculum, (2) 1:1 counseling with a registered dietitian, (3) behavioral skills development, (4) group support, and (5) commercially available wearable technology and smart scales for self-monitoring of physical activity, sleep, and body weight.

Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight

This study is a multicenter, randomized, double-blind, placebo-controlled phase II study conducted in China. It aims to evaluate the efficacy and safety of MWN109 injection in non-diabetic overweight or obese participants. A total of 125 participants were enrolled in the study. All participants were randomly assigned using stratified block randomization by gender (male or female) and allocated to 4 treatment groups at a 1:1:1:1 ratio, with approximately 30 participants in each group. Each treatment group will reach the target dose through dose titration. This study consists of a screening period of up to 2 weeks, a treatment period of 36 weeks, and a follow-up period of 4 weeks, totaling 42 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 36 weeks of drug administration. The secondary endpoints include the proportions of participants with a body weight reduction of ≥5%, ≥10%, ≥15%, and ≥20% relative to the baseline after 36 weeks of treatment, as well as the change in waist circumference relative to the baseline.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity

This study is a multicenter, randomized, double-blind, placebo-controlled phase II study conducted in China. It aims to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity. A total of 120 participants were enrolled in the study. All participants were randomly assigned using stratified block randomization by gender (male or female) and allocated to 4 treatment groups at a 1:1:1:1 ratio, with approximately 30 participants in each group. Each treatment group will reach the This study consists of a screening period of up to 2 weeks, a treatment period of 24 weeks, and a follow-up period of 2 weeks, totaling 28 weeks. The primary endpoint is the percentage change in body weight compared to the baseline after 24 weeks of drug administration. The secondary endpoints include the proportions of participants with a body weight reduction of ≥5%, ≥10%, ≥15%, and ≥20% relative to the baseline after 24 weeks of treatment, as well as the change in waist circumference relative to the baseline.target dose through dose titration.

Phase Ib Clinical Study of MWN109 Injection in Participants With Overweight or Obesity

This study is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity characteristics of MWN109 injection in Chinese non-diabetic participants with overweight or obesity. A total of 40 participants were enrolled in the study. All participants were stratified and randomized by gender in blocks, and randomly assigned to 4 dose groups at a ratio of 1:1:1:1, with 10 participants in each group(8 participants received MWN109 injection, and 2 received placebo). Each treatment group will use a dose titration method to reach the target dose. The study includes a maximum screening period of up to 2 weeks, a 14-week treatment period and a 2-week follow-up period, totaling 18 weeks. The primary endpoint is the incidence of adverse events. The secondary endpoint is the pharmacokinetic characteristics.