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The trial is taking place at:
A

Adobe Clinical Research, LLC | Tucson, AZ

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

C

CinDome Pharma

Status and phase

Enrolling
Phase 2

Conditions

Diabetic Gastroparesis

Treatments

Drug: Placebo
Drug: CIN-102 Dose 2
Drug: CIN-102 Dose 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT05832151
CIN-102-123

Details and patient eligibility

About

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 (5 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 1
  • Drug- CIN-102 Dose 2
  • Drug- Placebo

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Is a male or female ≥18 years of age;

  • Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;

  • Has a current diagnosis of diabetic gastroparesis defined by the following:

    1. Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND
    2. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry.
  • Body mass index (BMI) between 18 and 45 kg/m2, inclusive;

  • Glycosylated hemoglobin (HbA1c) level <10% at Screening;

  • If receiving treatment with GLP-1RA, may be considered for the study if all of the following criteria are satisfied:

    1. Has been on a stable dose of GLP-1RA for a minimum of 3 months before Screening and is anticipated to sustain the same dose during GEBT and throughout the study;
    2. Is tolerating the GLP-1RA well based on Investigator's judgment;
    3. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
    4. The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
  • Willing to washout from ongoing treatment for gastroparesis.

Key Exclusion Criteria:

  • Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesis and/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, or other neurologic disorder);
  • History or evidence of clinically significant arrhythmia;
  • History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery;
  • Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression;
  • Pyloric injection of botulinum toxin within 6 months of Screening;
  • Positive test for drugs of abuse;
  • Has a known allergy to eggs or spirulina;
  • Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

400 participants in 3 patient groups, including a placebo group

CIN-102 Dose 1
Experimental group
Description:
Dose 1 twice daily for 12 weeks
Treatment:
Drug: CIN-102 Dose 1
CIN-102 Dose 2
Experimental group
Description:
Dose 2 twice daily for 12 weeks
Treatment:
Drug: CIN-102 Dose 2
Placebo
Placebo Comparator group
Description:
Placebo twice daily for 12 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

94

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Central trial contact

Rachael Farley

Data sourced from clinicaltrials.gov

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