ASC30 for Obesity

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ascletis Pharma (China) Co., Limited

Disqualifiers: Diabetes, Autoimmune disease, Pancreatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

115 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASC30 injection

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that ASC30 for Obesity is an effective treatment?

The available research does not provide specific data on ASC30 for Obesity, so we cannot determine its effectiveness from the information given. The studies focus on other aspects of obesity treatment, such as the importance of long-term support and the challenges in recognizing and documenting obesity. Without direct data on ASC30, we cannot compare it to other treatments or confirm its effectiveness. ^{1 2 3 4 5}

What safety data exists for ASC30 in treating obesity?

The provided research does not contain specific safety data for ASC30 or any treatment under that name for obesity. The studies focus on obesity management, coding practices, and patient safety incidents related to obesity, but do not mention ASC30 or its safety profile. ^{6 7 8 9 10}

Is the drug ASC30 a promising treatment for obesity?

The information provided does not directly mention ASC30 or its effects on obesity, so we cannot determine if ASC30 is a promising treatment for obesity based on this data. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for non-smoking adults aged 18-65 with obesity, who have no significant medical history, abnormal ECGs, vital sign issues or other screening concerns. It's not for those with gastric emptying problems, drug/alcohol abuse, eating disorders, pancreatitis, chronic diseases, immune system issues or any cancer history.

Inclusion Criteria

Have provided informed consent before initiation of any study-specific procedures

I am between 18 and 65 years old and do not smoke.

My recent health screenings and tests show no significant issues.

Exclusion Criteria

Participants with a known clinically significant gastric emptying abnormality

Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol

I have a history of pancreatitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of ASC30 injection to evaluate safety and tolerability

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• ASC30

Trial Overview The study tests the safety and tolerability of a new injection called ASC30 compared to a placebo in people with obesity. Participants will be randomly assigned to receive either ASC30 or a placebo without knowing which one they're getting.

Participant Groups

Group I: SAD Cohort 8 Experimental Treatment 1 Intervention

SAD Dose 8

Group II: SAD Cohort 7 Experimental Treatment 1 Intervention

SAD Dose 7

Group III: SAD Cohort 6 Experimental Treatment 1 Intervention

SAD Dose 6

Group IV: SAD Cohort 5 Experimental Treatment 1 Intervention

SAD Dose 5

Group V: SAD Cohort 4 Experimental Treatment 1 Intervention

SAD Dose 4

Group VI: SAD Cohort 3 Experimental Treatment 1 Intervention

SAD Dose 3

Group VII: SAD Cohort 2 Experimental Treatment 1 Intervention

SAD Dose 2

Group VIII: SAD Cohort 1 Experimental Treatment 1 Intervention

SAD Dose 1

Group IX: MAD Cohort 3 Experimental Treatment 1 Intervention

MAD Dose 3

Group X: MAD Cohort 2 Experimental Treatment 1 Intervention

MAD Dose 2

Group XI: MAD Cohort 1 Experimental Treatment 1 Intervention

MAD Dose 1

Who Is Running the Clinical Trial?

Ascletis Pharma (China) Co., Limited

Lead Sponsor

Trials

3

Recruited

180+

Findings from Research

Successful treatment of obesity should not only focus on weight loss but also consider other measures like body mass index, body fat percentage, and improvements in obesity-related health complications such as diabetes and hypertension.

As obesity is a chronic disease, maintaining weight loss is crucial, and treatment success should be defined with varying criteria for minimal, intermediate, and full success based on individual responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposed standards for judging the success of the treatment of obesity. Atkinson, RL.[2019]

Obesity is a growing epidemic, particularly among children and adolescents, with significant associations to serious health risks such as cardiovascular disease, diabetes, and increased mortality rates.

Weight loss can lead to a substantial reduction in the risk of obesity-related comorbidities, highlighting the importance of identifying these conditions for better patient management and intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The medical risks of obesity. Pi-Sunyer, X.[2022]

Only 59.9% of patients with obesity recognized their weight as obese, highlighting a significant gap in self-perception that could hinder treatment efforts.

Physician documentation of obesity was low overall, with only 42.4% of patients having their obesity documented in the past year, indicating a need for better recognition and communication between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perception of obesity versus physician documentation of obesity: A quality improvement study. Mawardi, G., Kirkland, EB., Zhang, J., et al.[2019]

In a study of 36 obese individuals who completed a 12-month weight loss program, those receiving 18 months of dietary and psychological support maintained significantly greater weight loss compared to those who received no additional care, with an average weight change of -3.83 kg versus +2.48 kg.

The findings suggest that post-therapeutic support, including cognitive behavioral therapy and nutritional education, can enhance long-term weight maintenance, even for individuals with genetic predispositions to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Long-Term Dietitian and Psychological Support of Obese Patients Who Have Reduced Their Weight Allows Them to Maintain the Effects. Iłowiecka, K., Glibowski, P., Skrzypek, M., et al.[2021]

Implementing an optimal care path (OCP) for patients undergoing gastric bypass or laparoscopic adjustable gastric banding led to a significant reduction in hospital stay length from 6.5 days to 5.4 days, which is a 16.9% decrease.

The use of OCP also resulted in a 17.6% reduction in average total charges, amounting to $2,683, while improving communication and collaboration among healthcare team members, indicating that quality of care was maintained or improved alongside cost savings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting the challenge of managed care through clinical pathways for bariatric surgery. Rouse, AD., Tripp, BL., Shipley, S., et al.[2007]

Primary care providers face significant barriers in managing obesity, categorized into three main themes: obstacles related to the providers themselves, organizational challenges, and perceptions of patient-related issues.

The study highlights that obesity management is currently ineffective in primary care settings, indicating a need for targeted strategies to overcome these identified obstacles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions, Attitudes, and Behaviors of Primary Care Providers Toward Obesity Management: A Qualitative Study. Bornhoeft, K.[2018]

ICD-9 codes for obesity were significantly underutilized, with less than 10% of patients classified as overweight or obese receiving the appropriate coding, despite over 70% of the sample falling into these categories.

Patients with extreme obesity (BMI >40 kg/m) were more likely to have an ICD-9 code compared to those with a BMI between 25 and 40 kg/m, highlighting a need for improved coding practices to better identify obesity as a comorbidity and manage associated health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are International Classification of Diseases Codes in Electronic Health Records Useful in Identifying Obesity as a Risk Factor When Evaluating Surgical Outcomes? Goode, V., Rovnyak, V., Hinton, I., et al.[2019]

A total of 388 patient safety incidents related to obesity were analyzed, revealing that most incidents were linked to infrastructure issues, indicating a lack of adequate care provisions for obese patients in hospitals.

While most incidents resulted in no or low harm, the report highlighted three deaths associated with anaesthesia, underscoring the critical need for improved safety measures and training for healthcare providers managing obese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety incidents associated with obesity: a review of reports to the National Patient Safety Agency and recommendations for hospital practice. Booth, CM., Moore, CE., Eddleston, J., et al.[2016]

A 12-month intervention at an Australian hospital significantly improved the accuracy of obesity data recording, leading to better measurement of patient BMI through enhanced staff education and the use of tools like tape measures.

The intervention resulted in increased sensitivity and reduced false negatives in obesity data, highlighting the importance of accurate obesity recording for managing healthcare risks associated with rising obesity rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of a Clinical Practice Intervention in Increasing Obesity Data Recording at a Western Australian Country Health Service Hospital: A Quasi-Experimental Controlled Trial. McClean, K., Cross, M., Reed, S.[2022]

Approximately 97 million adults in the U.S. are overweight or obese, significantly increasing their risk for serious health issues such as type 2 diabetes, heart disease, and various cancers.

Obesity not only raises the risk of physical health problems but also contributes to social stigmatization and discrimination, highlighting its impact as a major public health challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive summary of the clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. [2022]

In a study of 46 women, higher levels of ZFP36 gene expression in omental adipose tissue were linked to lower fasting insulin levels and reduced insulin resistance, suggesting a protective role against diabetes.

ZFP36 expression was positively correlated with higher levels of adiponectin, a hormone that helps regulate glucose levels and fatty acid breakdown, indicating its potential importance in metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visceral adipose tissue zinc finger protein 36 mRNA levels are correlated with insulin, insulin resistance index, and adiponectinemia in women. Bouchard, L., Vohl, MC., Deshaies, Y., et al.[2016]

In a study of 262 obese individuals and 138 controls, no strong associations were found between specific genetic polymorphisms (LEPR, B3-AR, 5-HTT, and IRS-1) and obesity, suggesting these genes may not be major contributors to obesity risk.

However, weak but significant associations were noted for the HTT and LEPR loci, indicating that these genetic factors might have a minor influence on body mass index (BMI) status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LEPR, ADBR3, IRS-1 and 5-HTT genes polymorphisms do not associate with obesity. Mergen, H., Karaaslan, C., Mergen, M., et al.[2022]

In a study involving 556 individuals undergoing an 8-week low-calorie diet, the gene GDF15 was found to be upregulated during weight loss, indicating its potential role in the body's response to calorie restriction.

The research highlighted that GDF15 is expressed in anti-inflammatory macrophages and preadipocytes, suggesting it may play a significant role in mediating inflammation and metabolic changes associated with weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network Analyses Reveal Negative Link Between Changes in Adipose Tissue GDF15 and BMI During Dietary-induced Weight Loss. Imbert, A., Vialaneix, N., Marquis, J., et al.[2022]

Obesity affects over 25% of the global population and is linked to serious health risks such as type 2 diabetes, cardiovascular disease, and fertility issues.

Research has identified over 150 genetic loci associated with obesity traits, emphasizing the importance of adipose tissue and the central nervous system in understanding obesity's biological mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The genetic underpinnings of body fat distribution. Pulit, SL., Laber, S., Glastonbury, CA., et al.[2019]

In a study of over 14,000 participants from the Atherosclerosis Risk in Communities Study, the FTO rs9939609 A allele was linked to a higher risk of diabetes and obesity in white individuals, indicating a strong genetic influence on these conditions.

In contrast, among African-Americans, the FTO rs1421085 C allele was associated with increased obesity risk but surprisingly showed a protective effect against diabetes, highlighting the complex and race-dependent nature of genetic factors influencing these health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of type 2 diabetes and obesity is differentially associated with variation in FTO in whites and African-Americans in the ARIC study. Bressler, J., Kao, WH., Pankow, JS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Proposed standards for judging the success of the treatment of obesity. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The medical risks of obesity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Patient perception of obesity versus physician documentation of obesity: A quality improvement study. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Long-Term Dietitian and Psychological Support of Obese Patients Who Have Reduced Their Weight Allows Them to Maintain the Effects. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Meeting the challenge of managed care through clinical pathways for bariatric surgery. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Perceptions, Attitudes, and Behaviors of Primary Care Providers Toward Obesity Management: A Qualitative Study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Are International Classification of Diseases Codes in Electronic Health Records Useful in Identifying Obesity as a Risk Factor When Evaluating Surgical Outcomes? [2019]

8. England pubmed.ncbi.nlm.nih.gov

Patient safety incidents associated with obesity: a review of reports to the National Patient Safety Agency and recommendations for hospital practice. [2016]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of a Clinical Practice Intervention in Increasing Obesity Data Recording at a Western Australian Country Health Service Hospital: A Quasi-Experimental Controlled Trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Executive summary of the clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Visceral adipose tissue zinc finger protein 36 mRNA levels are correlated with insulin, insulin resistance index, and adiponectinemia in women. [2016]

12. Japan pubmed.ncbi.nlm.nih.gov

LEPR, ADBR3, IRS-1 and 5-HTT genes polymorphisms do not associate with obesity. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Network Analyses Reveal Negative Link Between Changes in Adipose Tissue GDF15 and BMI During Dietary-induced Weight Loss. [2022]

14. England pubmed.ncbi.nlm.nih.gov

The genetic underpinnings of body fat distribution. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Risk of type 2 diabetes and obesity is differentially associated with variation in FTO in whites and African-Americans in the ARIC study. [2022]