Health Trials

A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide

ConditionsOverweightObesity
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female (sex at birth).

Age 18 years or above at the time of signing the informed consent.

Disqualifiers

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.

History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.

Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues within 1 year before screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zenagamtide

    Drug

    Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • Semaglutide

    Drug

    Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • Placebo (matched to semaglutide)

    Drug

    Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • Placebo (matched to zenagamtide)

    Drug

    Placebo matched to zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Treatment groups

650 Participants
are divided into 3 treatment groups
Group A: ZenagamtideExperimental treatment 2 interventions
Group B: Semaglutide dose 1Active comparator 2 interventions
Group C: Semaglutide dose 2Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Relative change in body weight

Measured as percentage (%) change in body weight.

Time frame
From week 0 to week 84

Secondary outcomes

1

Change in waist circumference

Measured as centimetre (cm).

Time frame
From week 0 to week 84

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: