A Research Study Looking at the Effect of Timing of Meal After Dosing and Water Volume at Dosing on How the Medicine Zenagamtide is Taken up by the Body of Participants With Overweight or Obesity

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

The purpose of this clinical study is to test how taking zenagamtide tablets with different meal/water variations affects how much zenagamtide enters the bloodstream in people who have overweight or obesity. All participants will get zenagamtide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female (sex assigned at birth, inclusive of all gender identities).

Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Disqualifiers

Known or suspected hypersensitivity to study intervention(s) or related products.

Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.

Unusual meal habits (including, but not limited to, eating disorders) and special diet

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zenagamtide injection

    Drug

    Zenagamtide will be administered to one of the body parts: thigh, abdomen or upper arm

  • Zenagamtide tablet

    Drug

    Zenagamtide tablet will be taken in the morning in fasted state.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Zenagamtide subcutaneous (s.c.)Experimental treatment 1 intervention
Group B: Zenagamtide oralExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state

Measured as nanomoles per liter hourly (h\*nmol/L)

Time frame
From 0 (pre-dose) up to Day 196 and Day 224

Secondary outcomes

1

Cmax, zenagamtide, ss: maximum observed plasma concentration of zenagamtide at steady state

Measured as nanomoles per liter (nmol/L)

Time frame
From Day 196 to Day 197 and from Day 224 to Day 225
2

tmax, zenagamtide, ss: the time to maximum observed plasma concentration of zenagamtide at steady state

Measured as hours

Time frame
From Day 196 to Day 197 and from Day 224 to Day 225
3

t1/2, ss; the terminal half-life of zenagamtide after the last dose

Measured as hours

Time frame
From pre-dose on Day 224 until completion of Day 252

Other outcomes

Sponsors and contacts

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