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Weekly injection helps shed pounds in major weight loss trial

NCT ID NCT04251156

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a once-weekly injection of semaglutide (2.4 mg) to help people with overweight or obesity lose weight. About 375 adults took part, some receiving the drug and others a placebo, along with lifestyle advice. The main goal was to see how much weight they lost over 44 weeks. Results showed significant weight reduction, making it a promising option for long-term weight management.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

375 people

The number who actually took part.

Started

Dec 2020

Finished

Aug 2022

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, age 18 years or older at the time of signing informed consent * History of at least one self-reported unsuccessful dietary effort to lose body weight For subjects without T2D at screening: * Body mass index (BMI) of : * greater than or equal to 30 kg/m\^2 * greater than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease For subjects with T2D at screening: * Diagnosed with T2D above or equal to 180 days prior to the day of screening * Treated with either: * diet and exercise alone or * stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label * HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) * BMI greater than or equal to 27 kg/m\^2 Exclusion Criteria: * A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records For subjects without T2D at screening: \- HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening For subjects with T2D at screening : * Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m\^2 (below 60 mL/min/1.73 m\^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 2 Obesity Overweight

Contacts and locations

Locations

  • Ajou University Hospital

    Gyeonggi-do, 16499, South Korea

  • Beijing Luhe Hospital Capital Medical University

    Beijing, Beijing Municipality, 101100, China

  • Beijing Pinggu Hospital-Endocrinology

    Beijing, Beijing Municipality, 101200, China

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, São Paulo, 01228-200, Brazil

  • Cangzhou People's Hospital

    Cangzhou, Hebei, 061000, China

  • Cangzhou People's Hospital-Endocrinology

    Cangzhou, Hebei, 061000, China

  • Changzhou No.2 People's Hospital, Yanghu Branch

    Changzhou, Jiangsu, 213003, China

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing Municipality, 100853, China

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000, China

  • Fujian Medical University Union Hospital-Endocrinology

    Fuzhou, Fujian, 350001, China

  • General Hospital of Tianjin Medical University-Endocrinology

    Tianjin, Tianjin Municipality, 300052, China

  • Harrison International Peace Hospital-Endocrinology

    Hengshui, Hebei, 053000, China

  • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

    Hengshui, Hebei, 053000, China

  • Huashan Hospital Fudan University-Endocrinology

    Shanghai, Shanghai Municipality, 200040, China

  • Inner Mongolia People's Hospital-Endocrinology

    Hohhot, Inner Mongolia, 010020, China

  • Instituto de Ciências Farmacêuticas de Estudos e Pesquisas

    Aparecida de Goiânia, Goiás, 74935-530, Brazil

  • Jiangsu Province Hospital-Endocrinology

    Nanjing, Jiangsu, 210029, China

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shanghai Fifth People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 200240, China

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 201200, China

  • Shanghai Tenth People's Hospital (Tenth People's of Tongji University)-Endocrinology

    Shanghai, Shanghai Municipality, 200072, China

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001, China

  • The First Affiliated Hospital of Anhui Medical University-Endocrinology

    Hefei, Anhui, 230061, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Bethune hospital of Jilin University-Endocrinology

    Changchun, Jilin, 130061, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101, China

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu, 210011, China

  • The Second Hospital of Hebei Medical University-Endocrinology

    Shijiazhuang, Hebei, 050000, China

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211, China

  • The affiliated Hospital of Inner Mongolia Medical University-Endocrinology

    Hohhot, Inner Mongolia, 010050, China

  • Tongren Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200336, China

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