ASC35 Injection in People with Overweight or Obesity
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight
Run by Ascletis Pharma Inc · NCT07842640 · Data updated 2026-11-12
This study tests ASC35 injections to see if they are safe and well tolerated in adults with overweight or obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Ascletis Pharma Inc Industry-sponsored |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | August 27, 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07842640 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 65 with overweight or obesity who meet all health-screening criteria and provide informed consent.
✕Probably not a fit
Individuals with active significant diseases, diabetes, pancreatitis history, or immunocompromising conditions may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, randomized, double-blind, placebo-controlled study with single and multiple ascending doses of ASC35 delivered by subcutaneous injection. Participants will receive ASC35 or placebo to assess safety, tolerability, and how the drug behaves in the body, along with pharmacodynamic effects. The trial also includes an active comparator, tirzepatide, to provide context for responses. Eligible adults will undergo screening and will be monitored for adverse events, vital signs, and lab parameters throughout the dosing period. The study is conducted at a single Ascletis clinical site in Baltimore, MD, led by Ascletis Pharma.
Why it matters
Potential benefit: Participants may experience exploratory benefits from the study drug, though primary goals are safety and pharmacokinetics.
How similar studies have gone: Early-phase studies of similar injectable therapies have shown safety profiles that support further development, though this specific ASC35 approach is investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site. * Are between 18 and 65 years of age (both inclusive) at time of screening. * No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures. Exclusion Criteria: * Have evidence of any clinically significant active or chronic disease. * Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma. * Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * Have a history of acute or chronic pancreatitis. * Have a known clinically significant gastric emptying abnormality. * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy. * 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.
Where it's running
-
Ascletis Clinical Site
Baltimore, Maryland, United States Recruiting
Study contacts
- Study coordinator: Ascletis Recruiting
- Email: clinicaltrials@ascletis.com
- Phone: +1 2068073688
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ASC36 tablets in adults with obesity or overweight
A small study will test ASC36 tablets to see if they are safe and tolerated in adults with obesity or overweight, compared to placebo.
-
Two ASC36 injections in adults with obesity or overweight
A small early study tests two ASC36 injections and their placebos to see if they are safe and how they behave in the body for adults with obesity or overweight.
-
Once-daily ASC30 for adults who are overweight or obese with weight-related health issues
This study tests whether three different daily doses of ASC30 can help adults who are overweight or obese with related health problems lose weight and stay safe.
-
Once-daily ASC30 to See if it helps adults with obesity or overweight and Type 2 diabetes
This study tests three daily doses of ASC30 against placebo in adults who are overweight or obese and have Type 2 diabetes to see if it helps with weight loss and safety over time.
-
Aleniglipron for adults with overweight/obesity and type 2 diabetes
A long-term test to see if aleniglipron helps weight loss and blood sugar control in adults who are overweight or obese and have type 2 diabetes.
-
Aleniglipron for weight management in obesity or overweight with a related condition
This study tests whether aleniglipron, taken daily, helps people with obesity or overweight plus a weight-related condition lose weight when added to a reduced-calorie diet and more activity, compared with a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.