Las Vegas, NV

American Institute of Medical Research

Gastroparesis

Cardiovascular Diseases

Deudomperidone

CIN-102

Olpasiran

Amgen

CinDome Pharma

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients.

The main questions it aims to answer are:

* To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo
* To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo

Participants will go through the following schedule:

* Screening period (1-2 visits)
* Lead-in period (1 visit)

  * Will complete a Gastric Emptying Breath Test (GEBT)
  * Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation
* 12-week treatment period (7 visits)

  * Study drug taken twice daily by mouth
  * Will complete daily diaries and other PROs as described in protocol
* 1 week follow-up (1 visit)

Researchers will compare the effects of the following treatments:

* Drug- CIN-102 Dose 15 mg or 10 mg
* Drug- Placebo

A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\[a\]).

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

American Institute of Medical Research | Las Vegas, NV

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Active trials

A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

Trial sponsors