Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin Therapy for Pulmonary Non-Tuberculous Mycobacterium Disease

Date Added
January 27th, 2026
PRO Number
Pro00147995
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Nontuberculous mycobacteria (NTM), Pulmonary
Summary

The purpose of the study is to learn more about an experimental drug called ORC-13661 that may be helpful in treating hearing loss due to antibiotic use. The study is researching whether the drug is safe and tolerable, and trying to find out whether the drug may be able to mitigate or prevent hearing loss in patients being treated with intravenous (IV) amikacin. Participation in the study will consist of up to 10 visits over up to 129 days. The Day 1 visit (following the screening visit) will last up to 8 hours, while other visits will last up to 5 hours Participants will be randomly assigned to receive either ORC-13661at a higher dose or a lower dose or a placebo (a pill that looks the same as the study drug but has no real medicine in it), for up to 90 days to be taken along with IV amikacin. Participants will be asked to have a number of tests and procedures, which include questionnaires about family, medical, and hearing history, physical and hearing examination, and assessments of hearing.

Institution
MUSC
Recruitment Contact
Rohini Rao
8437926109
recruitment@musc.edu

An Open-label, Phase 1/2 Trial of Gene Therapy 4D-710 in Adults with Cystic Fibrosis

Date Added
January 27th, 2026
PRO Number
Pro00146219
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

The study will test an investigational drug known as 4D-710. An "investigational drug" is one that has not yet been approved for use by a Health Authority such as the United States Food and Drug Administration (FDA). 4D-710 is being studied as a potential treatment for cystic fibrosis lung disease. This is the first study to test 4D-710 in humans. The purpose of this study is to see if 4D-710 is safe for use in adults with cystic fibrosis and to see if 4D-710 can help lung function.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1)

Date Added
February 26th, 2026
PRO Number
Pro00148568
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

A 144-week clinical research study to look at how well an investigational obesity medicine works, along with a reduced-calorie diet and increased physical activity in participants with obesity.
The medicines are injected subcutaneously (under the skin) once a week.
This study also includes a placebo.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 years of age and older with Bronchiectasis and Chronic Pseudomonas aeruginosa Colonization

Date Added
June 2nd, 2026
PRO Number
Pro00151105
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis, Lung, Pulmonary
Summary

This study is being conducted to evaluate the drug AZD0292, including how safe it is, how long it stays in the blood, and if it may help in reducing the number of exacerbations in people with Pseudomonas aeruginosa in their lungs. These patients have more frequent lung exacerbations and reduced quality of life. Pseudomonas aeruginosa is a bacteria that can make the symptoms of bronchiectasis worse. The study drug (AZD0292) works by attaching to Pseudomonas aeruginosa, thereby reducing its effects on the lungs and improving symptoms.
This study aims not only to test AZD0292 but is also being done to better understand bronchiectasis disease and its associated health problems.
Study drug (AZD0292) or placebo, will be given to participants as an intravenous (IV) infusion. The study is double-blinded.
About 435 participants with bronchiectasis 12 years of age and older, weighing at least 35kg will take part in this study. This study will be conducted globally in approximately 25 countries.

Institution
MUSC
Recruitment Contact
Rohini Rao
8437926109
recruitment@musc.edu

Efficacy and safety of once-daily oral zenagamtide in participants with obesity (AMAZE 9)

Date Added
August 13th, 2026
PRO Number
Pro00151743
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

An 87-week clinical research study comparing zenagamtide in doses of 6mg, 12mg, 25mg, 50 mg or 2 x 50mg versus placebo, all administered as once-daily oral tablets as an adjunct to a reduced-calorie diet and increased physical activity, in participants with obesity.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

Efficacy and safety of zenagamtide s.c. once-weekly compared to semaglutide s.c. once-weekly in participants with obesity (AMAZE 7)

Date Added
September 24th, 2026
PRO Number
Pro00151883
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

A 95-week study comparing the efficacy and safety of a specific dose of a trial product named zenagamtide versus two different doses of semaglutide, administered once weekly via injection along with a reduced-calorie diet and increased physical activity on weight management in participants with obesity.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu



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