ASC47 + Semaglutide for Weight Management

Overseen By Yvonne Li, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ascletis Pharma (China) Co., Limited

Disqualifiers: Obesity, Malignancy, Alcohol, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ASC47 (an experimental treatment), combined with semaglutide, to help manage weight in people with obesity. The study aims to determine the safety and effectiveness of different doses. Participants will receive one of three doses to identify which is most effective with the fewest side effects. Individuals struggling with obesity without medical causes, such as certain genetic conditions, might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ASC47 is likely to be safe for humans?

Research has shown that combining ASC47 with semaglutide has been studied for weight loss effects. In these studies, only 6.7% of patients using the combination experienced vomiting, compared to 57.1% of those using semaglutide alone. This suggests the combination might cause fewer stomach-related side effects.

However, this treatment remains in the early testing stages for this specific use. Early tests focus on safety, so information is limited. While some side effects are known, not all possible risks have been identified. Participants should consider this when deciding to join a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ASC47 combined with Semaglutide because it offers a fresh approach to weight management. Unlike other treatments that primarily focus on appetite suppression or metabolic rate increase, ASC47 targets a novel pathway to potentially enhance weight loss when used alongside Semaglutide. This combination aims to provide more effective weight reduction by optimizing how the body processes and stores energy, which could represent a significant advancement over current options. Additionally, the study is exploring different dosing cohorts to find the most effective and safe dosage, which could lead to personalized treatment options for individuals with obesity.

What evidence suggests that this trial's treatments could be effective for weight management?

Research has shown that using ASC47 with semaglutide results in greater weight loss compared to semaglutide alone. In earlier studies, this combination led to 56.2% more weight loss. Beyond aiding weight loss, ASC47 and semaglutide together also preserved muscle mass, which is important for maintaining health. This trial will evaluate different dosages of the ASC47 and semaglutide combination in participants with obesity. These findings suggest that using ASC47 with semaglutide could be a more effective treatment for obesity than semaglutide alone. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for non-pregnant, non-breastfeeding females who agree to use contraception and have had a stable body weight with no significant medical findings recently. It excludes those with autoimmune diseases, recent drug or alcohol abuse, obesity due to medical causes like hypothyroidism or Cushing syndrome, and anyone with a history of significant malignancy in the last 5 years.

Inclusion Criteria

I am not pregnant or breastfeeding and won't be for 6 months, and I agree to use birth control.

Subject have provided informed consent before initiation of any study specific procedures

Stable body weight (less than 5% self-reported change within the previous 3 months)

Exclusion Criteria

Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised

Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year

My obesity is due to a medical condition like a genetic disorder or hormonal imbalance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ASC47 in combination with semaglutide

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ASC47

Trial Overview The study tests ASC47 combined with Semaglutide against a placebo plus Semaglutide for weight management. It's phase I, randomized, double-blind and placebo-controlled involving screening, treatment periods and follow-up.

How Is the Trial Designed?

Group I: Combo Cohort 3 in participants with obesity Experimental Treatment 2 Interventions

Cohort 3, dose 3

Group II: Combo Cohort 2 in participants with obesity Experimental Treatment 2 Interventions

Cohort 2, dose 2

Group III: Combo Cohort 1 in participants with obesity Experimental Treatment 2 Interventions

Cohort 1, dose 1

Who Is Running the Clinical Trial?

Ascletis Pharma (China) Co., Limited

Lead Sponsor

Trials

3

Recruited

180+

Citations

1. prnewswire.com prnewswire.com/news-releases/ascletis-announces-asc47-in-combination-with-semaglutide-demonstrated-up-to-56-2-greater-relative-reduction-in-body-weight-in-participants-with-obesity-compared-to-semaglutide-monotherapy-302562415.html

Ascletis Announces ASC47 in Combination with ... On day 29, four weekly doses of semaglutide monotherapy demonstrated a 2.5% reduction in body weight from baseline, consistent with the reported ...

2. ascletis.com ascletis.com/data/upload/ueditor/20250618/ASC47_poster_@_ADA_2025.pdf

ASC47, a Muscle-Preserving Weight Loss Drug Candidate ... ASC47 low dose combination 1 showed more significant weight loss (-36.2%) than semaglutide monotherapy, achieving a 56.7% greater reduction in ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/847-P/159929/847-P-ASC47-a-Muscle-Preserving-Weight-Loss-Drug

847-P: ASC47, a Muscle-Preserving Weight Loss Drug ... Results: ASC47 low dose combination 1 demonstrated superior weight loss compared to semaglutide monotherapy, showing an average total body ...

4. pharmexec.com pharmexec.com/view/ascletis-muscle-preserving-weight-loss-drug-candidate-displayed-significant-improvement-body-weight-reduction-asc47-103-study

Ascletis' Muscle-Preserving Weight Loss Drug Candidate ... ASC47 combined with semaglutide achieved up to 56.2% greater weight reduction compared to semaglutide monotherapy in obese participants. The ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06972992

NCT06972992 | A Study to Evaluate Safety, Tolerability ... Evaluate the Terminal-Phase Half-Life of ASC47 in combination with semaglutide. Evaluate the Apparent Systemic Clearance of ASC47 in combination with ...

6. ascletis.com ascletis.com/news_detail/192/id/1150/l/en-us

ASC47 ... ASC47 in combination with semaglutide demonstrated a 56.7% greater reduction in body weight compared to semaglutide monotherapy. -U.S. Food ...

7. clival.com clival.com/news/ascletis-reports-strong-results-for-asc47-in-combination-with-semaglutide-in-obesity-trial

Ascletis Reports Strong Results for ASC47 in Combination ... GI Tolerability: Vomiting occurred in only 6.7% of patients receiving ASC47 + semaglutide, compared to 57.1% on semaglutide monotherapy. · Weight ...