Clinical Research Directory

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.

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.

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.

Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity. Approximately 760 participants will be enrolled. All participants will be stratified by gender (male or female) and baseline BMI level, and then randomized 1:1:1:1 to 4 treatment groups, with 190 participants per group. All treatment groups will implement dose titration to achieve the target dose. The study comprises a screening period of up to 2 weeks, a 52-week treatment period, and a 4-week follow-up period, for a total study duration of 58 weeks. The primary endpoints are the percentage change in body weight from baseline and the proportion of participants achieving ≥5% weight reduction from baseline at Week 52. The secondary endpoints include the proportions of participants achieving ≥10% and ≥15% weight reduction from baseline, as well as the change from baseline in waist circumference at Week 52.

Immediate Effect of Whole-Body Vibration on Cardiovascular Response and Functional Capacity in Overweight/Obese Young Women

Obesity has become a major global public health issue, defined by an excessive accumulation of body fat that presents substantial health risks. Over 650 million adults worldwide suffer from obesity, which is defined as having a Body Mass Index (BMI) of 30 or higher. Obesity is becoming more common in both developed and developing countries. Sedentary lifestyles, unhealthy eating habits that include processed foods and sugars, and genetic factors are the main causes of the rising prevalence of obesity. Obesity is a multifactorial condition that affects physical appearance and self-esteem, while also having significant implications for long-term health, leading to decreased life expectancy and lower quality of life.

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of CLB101TM️ on Gut Health in Healthy, Overweight Individuals

Anaerostipes caccae CLB101TM️ is a next-generation probiotic isolated from healthy humans. It was shown to be in decreased abundance in people with protein-based food sensitivities/allergies. CLB101TM️ is different from most commercially available probiotics in that it directly produces butyrate. Butyrate is a naturally occurring small molecule found in the gut of healthy individuals, and it has been shown to provide clinical benefits including strengthening the gut lining, providing immune health, and supporting a balanced microbiome. The rationale for developing CLB101TM️ is to provide a probiotic that generates butyrate in the targeted intestinal locations where it can optimally benefit cells that line the gut.

I-OPERA: A European Study Testing a New Way to Do Health Research.

The goal of this observational pilot study is to evaluate whether a participant-mediated, direct-to-participant research approach is a feasible and effective way to collect health data from adults living with obesity in England, France, and Germany. This approach allows participants to take part remotely and to help researchers access their medical records using their data access rights, while also providing information directly through an online questionnaire. The main questions it aims to answer are: 1. Can medical records be successfully obtained through participant-authorized data subject access requests (DSARs), and how long does the process take? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.) 2. How well do healthcare providers comply with requests for medical records? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest. Therefore, their healthcare providers are not contacted.) 3. Is the information collected through this approach complete and of sufficient quality for research purposes? 4. How closely does information reported by participants match the information contained in their medical records? 5. Are there differences in outcomes between countries and regions? Researchers will also explore the demographic, clinical and socio-economic characteristics of participants, assess health-related quality of life, evaluate experiences related to "food noise", and compare quality-of-life results across countries. There is no comparison group or study treatment, as this is an observational study. Participants will: * Provide electronic informed consent to participate in the study. * Authorize requests for their medical records using their legal right to access personal health information (DSAR). (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.) * Complete an online questionnaire about their health, quality of life, and experiences related to obesity. * Allow researchers to combine information from questionnaire with data obtained from their medical records. * Participate entirely remotely through the IQVIA Health Research Space (HRS) platform, with no study site visits required. Participation lasts for up to 90 days and includes completion of questionnaire and the medical record retrieval process. The study plans to enroll approximately 105 participants, with around 35 participants in each participating country.

Effect of Probiotics on Appetite Regulation in Adults With Overweight/Obesity

The goal of this 16-week randomised, placebo-controlled parallel study is to investigate the effect of a newly formed probiotic supplement on satiety and gut microbiota composition in healthy men and women with overweight or obesity form 20-70 years old. The main question it aims to answer is: Does the probiotic supplement increase feelings of satiety and alter gut microbiota composition? Participants will: * Receive a daily dose of 6 g probiotic supplement (packed in sachets of 3 g) or placebo for 16 weeks. * Visit the research unit 3 times at baseline, week 8 and week 16 of the intervention for blood draws and delivering fecal samples. * Keep a study diary to report deviations from their daily habits and fill in food questionnaires.

Dietary Guidelines for Americans-Ultra Processed Study

The purpose of this research is to test how processing food can affect how one's body responds to it.

Impact of Antioxidant-rich Supplementation on Skin Carotenoids Status, Antioxidant Status and Cardiometabolic Health in Overweight and Obese Individuals

This study aims to evaluate the effects of antioxidant-rich supplementation on skin carotenoid status, antioxidant status, and cardiometabolic health in overweight and obese individuals. The study may provide additional scientific evidence to support the further refinement of current dietary and nutritional recommendations.

A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)

This study will evaluate the percentage change in body weight from baseline and proportion of subjects achieving ≥ 5% weight loss from baseline after 52 weeks of treatment with Zovaglutide in subjects with overweight/obesity.

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.

ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY

The study is observational and single-center and involves (i) the establishment of a retrospective and prospective data collection, and (ii) the development of prognostic and predictive models of response to obesity therapies using statistical modeling and machine learning techniques, exclusively for research purposes. Data collection will be carried out for each patient diagnosed with obesity or overweight whose first visit to the center occurred from January 1, 2000 up to the start of the study, as well as for patients accessing the center during the subsequent 5 years, including patients who died or were lost to follow-up. With respect to the primary objective, an interim analysis is planned on the retrospective cohort only, once the collection of data already available at study start has been completed for patients with at least 5 years of follow-up. Data related to instrumental and laboratory examinations and therapeutic interventions, including pharmacological treatments and group-based educational and behavioral therapies, conducted in accordance with routine clinical practice and the most recent relevant national and international guidelines, will be extracted from the electronic health records routinely used at the study center.

SucroMet Nutritional Intervention Trial

SucroMet is designed to evaluate how adding two commonly used sweeteners-sucrose (table sugar) and sucralose (a low-calorie sweetener)-at low and high doses may influence glucose regulation, including insulin resistance and fasting plasma glucose, in adults aged 18 to 65 years with normal weight, overweight, or obesity. The low-dose intervention consists of 5% of the Estimated Energy Requirement (EER) from sucrose or 5 sucralose tablets per day (approximately 33.35 mg/day of sucralose). The high-dose intervention consists of 10% of EER from sucrose or 10 sucralose tablets per day (approximately 66.7 mg/day of sucralose). These doses maintain the planned 1:2 exposure ratio between the low- and high-dose intervention groups. Before the intervention begins, participants' habitual dietary intake is assessed and, when necessary, minor dietary adjustments are made to support a stable overall eating pattern while maintaining energy intake. Participants then complete a four-week run-in period during which these recommendations are followed, and dietary records are used to verify dietary stability before the intervention starts. Participants will consume the assigned sweetener incorporated into foods or beverages that they already consume as part of their habitual diet, without substantial changes to their usual eating patterns. The intervention includes two consecutive 12-week phases, one involving solid food intake and the other involving liquid intake, separated by a two-week washout period. This design allows evaluation of the effects of sweetener type, dose, and mode of consumption. The primary outcomes are changes in glucose regulation, including fasting plasma glucose and insulin resistance assessed by HOMA-IR. Secondary outcomes include changes in body composition, anthropometric measurements, blood pressure, routine biochemical parameters, gut microbiota composition, DNA methylation patterns in peripheral blood cells, and biomarkers related to inflammation, oxidative stress, and metabolomic profiles measured in blood and urine. Participants will attend scheduled study visits for anthropometric assessments, dietary evaluations, and biological sample collection. Blood, urine, and stool samples will be obtained at baseline and after each intervention phase. The study aims to address the following questions: 1. Do metabolic responses to sucrose and sucralose, including changes in insulin resistance (HOMA-IR) and fasting plasma glucose, differ according to participants' body mass index (BMI)? 2. Do low and high doses of sucrose and sucralose differentially affect glucose regulation, body composition, and metabolic health? 3. Does the mode of intake (solid versus liquid) influence changes in gut microbiota composition? 4. Are changes in DNA methylation patterns in peripheral blood cells associated with the consumption of sucrose and sucralose at different doses and in different forms? 5. Do different doses of sucrose and sucralose influence biomarkers related to inflammation, oxidative stress, and metabolomic profiles?

Efficacy and Safety of ZT006 in Overweight and Obese Participants

This study is being conducted to evaluate the efficacy and safety of ZT006 tablet in participants with overweight and obesity. In addition to dietary caloric restriction and increased physical activity, study participants will receive either ZT006 tablets or placebo tablets once every morning (placebo looks like ZT006 tablets but has no active pharmaceutical ingredients). For a fair comparison, study participants are assigned to ZT006 or placebo randomly by a computer. The study consists of a main study and an extension period. The treatment of the main study will last for 28 weeks. ZT006 tablets will be administered daily in an up-titration fashion, i.e. the dose of ZT006 will be gradually increased to reach three target doses (low, medium, high) so that the participants can tolerate its effect. Participants will have 17 clinic visits including one screening visit and one follow-up visit. The extension study will be conducted only in participants assigned to the low and medium dose groups in the main study. The treatment of the extension period will be 12 weeks. Female participants who are pregnant, breast-feeding or who plan to become pregnant during the study are not allowed to participate in the study. Pregnancy will be checked by blood or urine tests during the study.

A Study of SRSD384 in Overweight or Obese Participants

This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD384 alone in overweight or obese participants (Part A) and in combination with tirzepatide in overweight or obese participants with T2DM (Part B).

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults

The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.

Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

This study aims to employ a cluster randomized controlled trial to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among Overweight/Obese Individuals with Cardiometabolic Preconditions, thereby providing theoretical foundations and practical guidance for the prevention and management of this population.

A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants

This study is a single-dose, open-label, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with different degrees of renal insufficiency and matched participants with normal renal function.

Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents

The main purpose is to investigate the effectiveness of a 10-week multicomponent camp intervention to reduce BE behavior in children and adolescents and explore in a randomized controlled setting if a parent-based BED-intervention has any add-on effect, attenuating the development of BE behavior in this sample. The study will include an initial follow-up assessment scheduled 10-12 weeks after camp completion and plans for long-term follow-up assessments one, three and five years after inclusion. Overall, we hypothesize that the multicomponent camp intervention will effectively reduce BE behavior in children and adolescents. Furthermore, we hypothesize that participants whose parents are randomized to receive the parental BED intervention will show a lower prevalence of BE behavior one year after the camp intervention compared with children whose parents receive standard care.

Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity

Tirzepatide is one of the new medications for the treatment of obesity. In clinical research people treated with Tirzepatide have weight loss up to 21%. But there is only a little bit of research showing the effect of Tirzepatide in clinical practice. In this retrospective observational study the investigators will evaluate the effectiveness of tirzepatide in routine clinical practice among adults with obesity in the Netherlands.The main questions it aims to answer are: * How much weight do patients lose after six months of treatment with tirzepatide combined with lifestyle coaching? * How is the medication dosed in daily practice? Researchers will use data from electronic health records of patients in multiple outpatient locations of the Dutch Obesity Clinic (NOK, Nederlandse Obesitas Kliniek).

Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program

This study aims to evaluate the outcomes of an existing clinical program that teaches families of children with overweight and obesity healthy lifestyle. The design will be unblinded, randomized, waitlist control.

Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients

This is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in China. The study aims to evaluate the efficacy and safety of metformin combined with secukinumab in the treatment of moderate-to-severe plaque psoriasis in overweight or obese Chinese patients. A total of approximately 186 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either secukinumab plus metformin or secukinumab plus placebo. The study consists of a screening period, an induction period, a maintenance period, and a follow-up period, with a total duration of 60 weeks. The primary endpoints are the proportions of participants achieving PASI75 (≥75% improvement in Psoriasis Area and Severity Index) and an IGA score of 0 or 1 (clear or almost clear) at Week 24. Secondary endpoints include PASI90, quality of life (DLQI), pruritus NRS score, metabolic parameters, and safety assessments. This study aims to provide a more effective combination therapy for psoriasis patients with overweight or obesity.