RightFit
Not yet recruitingPhase 1

A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity

PHASE 1, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PARALLEL GROUP, PK COMPARABILITY STUDY BETWEEN DIFFERENT DELIVERY SYSTEMS OF BEROBENATIDE IN ADULTS WITH OVERWEIGHT OR OBESITY

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how different forms of berobenatide enter the blood after one dose, and how safe and effective they are. It is for adults with overweight or obesity, meaning more body fat than is healthy. The study includes several clinic visits.

This is a single dose study to learn how safe and effective the study medicine is using different delivery systems for adults with overweight or obesity. Overweight or obesity means having more body fat than what is healthy. The study involves multiple clinic visits at a study site over the length of the study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have a BMI of 27 to 45. BMI is a measure based on height and weight.
  • Weigh more than 50 kg (110 lb).

Who can't join

  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have a history of other long-term health conditions.
  • You or a parent, sibling, or child have had medullary thyroid carcinoma (MTC), a type of thyroid cancer, or multiple endocrine neoplasia type 2 (MEN2), a condition that can cause tumors in hormone-making glands. Suspected MTC also rules you out.
  • Have a serious problem with how your stomach empties, or regularly take medicines that directly affect how food moves through your stomach or intestines.
  • Have sudden or short-term stomach or bowel symptoms at screening, the day before treatment, or before getting the study medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Participants 18 years of age or older * BMI of 27-45 kg/m2; and a total body weight \>50 kg (110 lb) Key Exclusion Criteria: * Pregnant or breastfeeding women, or those planning pregnancy during the study * History of other chronic disorders * Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC * Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect gastrointestinal (GI) motility * Acute GI symptoms at screening, Day -1, or prior to administration of study intervention

Study sites (1)

CA