Can a monthly shot help people with obesity lose weight?
NCT ID NCT07794774
First seen Aug 31, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests an experimental drug called berobenatide, given as a once-monthly injection, to see if it helps adults with obesity lose weight. About 197 participants in Japan will receive either berobenatide or a placebo for roughly 21 months. The trial measures changes in body weight, waist size, and other health markers, and also checks the drug's safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- berobenatide, an experimental once-monthly injectable drug
- What this could lead to
- If it works, this could offer a convenient once-monthly option for weight loss in people with obesity, potentially reducing related health risks.
- What could go wrong
- This is a Phase 3 trial, but success is not guaranteed. The drug may cause side effects, and results in this Japanese population may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 197 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged ≥18 years. * BMI of: ≥27.0 kg/m2 to \<35.0 kg/m2 with ≥2 obesity-related health disorders or BMI of ≥35.0 kg/m2 with ≥1 obesity-related health disorder. The participant must have at least one of either hypertension, dyslipidemia or glucose intolerance (T2D and impaired glucose tolerance etc.) as an obesity-related health disorder. Exclusion Criteria: * Have a self-reported body weight change greater than 5% within 90 days prior to Screening. * Diagnosis of type 1 diabetes or any other form of diabetes other than T2D. * History of acute or chronic pancreatitis. * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
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Higashi-Shinjuku Clinic, Keikokai Medical Corp.
Shinjuku-ku, Tokyo, 169-0072, Japan
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Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, 171-0021, Japan
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Manda Memorial Hospital
Sapporo, Hokkaido, 060-0062, Japan
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Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, 565-0853, Japan
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Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008, Japan
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Nihonbashi Sakura Clinic
Tokyo, 103-0025, Japan
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Oishi Clinic
Kasuya-gun, Fukuoka, 811-2310, Japan
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Shimamura Memorial Hospital
Nerima-ku, Tokyo, 177-0051, Japan
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Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0027, Japan
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Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
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